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FDA Calendar 2026 Upcoming FDA Approval Dates & PDUFA Dates
Track every upcoming FDA approval date, PDUFA date, and biotech catalyst in one place. Our free FDA calendar is updated daily with clinical trial readouts, advisory committee meetings, drug approval decisions, and next FDA meeting dates for 2026. Built for biotech investors who need to stay ahead of stock-moving regulatory events.
Updated daily · Last refreshed Aug 15, 2026
Showing 6 Catalysts Out Of 1408. Click On The Tickers For More Details
| Company | Price | 30-Day Trend | Market Cap | Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Implied Move | Insiders | Hedge Funds | Risk | Cash | Burn Rate | Volume | Float Short | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 MRKMerck & Company, Inc. | 135.84 -0.04% | +7.1% | 335.50 B | PDUFA Date 2026-08-17 | KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv) muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy Priority | PDUFA | 85.5% KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), Merck's (MRK) subcutaneous formulation of the PD-1 inhibitor, is currently under FDA priority review for its use in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC) developed by Astellas and Seagen. This combination is intended for the perioperative treatment of muscle-invasive bladder cancer (MIBC) in adults who are eligible for cisplatin-based chemotherapy. The review follows the November 2025 approval of the same combination for patients ineligible for cisplatin, marking a significant advancement as the first PD-1/ADC regimen in this context. This approval was supported by phase 3 data demonstrating a 60% reduction in recurrence risk and a 50% reduction in mortality compared to surgery alone. The global market for MIBC is estimated at approximately $4-5 billion annually, with the segment of patients eligible for cisplatin-based therapy accounting for about $2-3 billion, representing roughly 50-60% of the patient population, as around 40% are deemed ineligible due to comorbidities. The unmet need in this space is moderate. While perioperative chemotherapy has been shown to improve outcomes, recurrence rates remain high, with around 50% of patients experiencing recurrence within five years. Established cisplatin regimens, such as gemcitabine combined with cisplatin, are entrenched as the standard of care, supported by level 1 evidence. The Keytruda QLEX and Padcev combination is positioned as best-in-class, leveraging both immunotherapy and ADC mechanisms, which have demonstrated superiority over traditional chemotherapy alone, as evidenced by interim data from the EV-304 trial showing a pathological complete response (pCR) rate of 55.8% compared to 32.5% with neoadjuvant gemcitabine/cisplatin. The ongoing phase 3 KEYNOTE-B15/EV-304 trial (NCT number not specified) is pivotal to the development of this combination, evaluating the efficacy of Padcev plus pembrolizumab against neoadjuvant gemcitabine/cisplatin in approximately 1,000 cisplatin-eligible MIBC patients. The primary endpoints of this trial are event-free survival (EFS) and overall survival (OS), with secondary endpoints including pCR. Interim results from related EV-304 data indicate a strong pCR benefit, with full phase 3 results expected to drive the supplemental biologics license application (sBLA), which has been accepted for priority review, with a target action date of August 17, 2026. Safety profiles are consistent with prior combination therapies, with serious adverse events reported in 50% of patients, including rash, acute kidney injury (AKI), and pneumonitis. Notable risks include hyperglycemia, diabetic ketoacidosis, and peripheral neuropathy, which have led to dose reductions in 13% of cases. Currently, there are no specific regulatory designations for cisplatin-eligible MIBC, although the priority review is significant for the sBLA itself. Merck has a strong track record with over 40 approvals for Keytruda, further bolstered by the partnership with Pfizer and Astellas. Recent precedents favor approval, particularly following the successful cisplatin-ineligible approval in November 2025 and the recent approval of enfortumab vedotin plus pembrolizumab in metastatic urothelial carcinoma based on strong OS and progression-free survival data. The competitive landscape includes other perioperative therapies such as durvalumab and nivolumab, which are currently under review, alongside established chemotherapy standards. The pCR and EFS advantages of the Keytruda QLEX and Padcev combination, along with its first-to-market status, support its potential for label expansion. The estimated probability of approval (PoA) stands at 85.5%, reflecting the positive trajectory of the phase 3 trial, the precedent set by prior approvals in the ineligible cohort, and the existing unmet need for reducing recurrence rates. However, risks remain, including the necessity for confirmatory OS data maturity and potential safety signals that could lead to restrictions. Upcoming catalysts hinge on the PDUFA date. For investors in Merck, approval would significantly enhance the dominance of Keytruda and Padcev in the bladder cancer market, with a potential peak sales runway exceeding $10 billion for Keytruda, thereby increasing its share in the perioperative setting compared to traditional chemotherapy. Read More | ±2.7% | -82.45 M | 2 +149% | HEALTHY | 8.36 K | 227.67 | 6.87 M | 1.17% | ||
MRKMerck & Company, Inc. | 135.84 -0.04% | +7.1% | 335.50 B | PDUFA Date 2026-08-17 | KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy Priority | PDUFA | 25.5% Merck's KEYTRUDA (pembrolizumab), an anti-PD-1 monoclonal antibody, in combination with Astellas/Seagen's Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody-drug conjugate, represents a significant advancement in the treatment of advanced bladder cancer. This first-in-U.S. anti-PD-1 and ADC regimen has already transformed the treatment landscape for locally advanced and metastatic urothelial carcinoma (la/mUC) and is now poised to expand into the perioperative treatment of muscle-invasive bladder cancer (MIBC) for cisplatin-eligible patients. Currently, the standard of care for this patient population remains neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy. The global market for cisplatin-eligible MIBC is estimated to reach $2.5 billion by 2026, driven by approximately 15,000 to 20,000 annual incident cases in the U.S. and EU that are suitable for perioperative therapy. However, the unmet need in this segment is relatively low, as cisplatin regimens have established a roughly 50% five-year survival rate. Recent data indicate that while there are modest event-free survival (EFS) gains with the addition of immune-oncology therapies, such as KEYTRUDA monotherapy, the improvements are not substantial enough to create a significant gap compared to emerging perioperative regimens. The development status of the KEYTRUDA and Padcev combination is currently at the PDUFA stage, although public data on the trial outcomes is limited. The pivotal Phase 3 EV-303 trial (NCT03983954) evaluated this combination in cisplatin-ineligible MIBC patients, demonstrating a 60% reduction in EFS event risk (HR=0.40; p<0.0001) and a 50% reduction in overall survival (OS) risk (HR=0.50; p=0.0002) compared to surgery alone. However, there is no dedicated readout for cisplatin-eligible patients, which raises concerns regarding the applicability of these results to this specific population. Previous approvals for la/mUC were based on data from the EV-302/KEYNOTE-A39 trial, which reported an overall response rate of 68% compared to 44% for chemotherapy, resulting in full approval in December 2023. Regulatory designations for the combination in the cisplatin-eligible MIBC population are absent, as the previous breakthrough therapy designation was granted for la/mUC in 2020. The competitive landscape is robust, with established perioperative options, including cisplatin chemotherapy with or without immune-oncology agents. Emerging threats from pipeline candidates, such as tarlatamab and sacituzumab govitecan, further complicate the market dynamics. The estimated probability of approval (PoA) for the KEYTRUDA and Padcev combination stands at 25.5%. This figure reflects the risks associated with the lack of dedicated Phase 3 data for cisplatin-eligible MIBC, as the FDA may require evidence of EFS and OS superiority in a population accustomed to aggressive chemotherapy. Additionally, potential toxicity issues, including neuropathy and immune-related adverse events, may limit the benefits of the combination therapy. Despite these challenges, Merck's strong track record with KEYTRUDA, which has garnered over 40 approvals, and the collaboration with Pfizer/Astellas enhance the likelihood of success. Nevertheless, the absence of trial data specific to cisplatin-eligible patients means that approval will depend heavily on extrapolation from existing studies. Investors should be aware of the high-risk, high-reward nature of this opportunity, with the potential for significant upside contingent on forthcoming data and regulatory decisions. Read More | ±2.7% | -82.45 M | 2 +149% | HEALTHY | 8.36 K | 227.67 | 6.87 M | 1.17% | ||
 BMYBristol-Myers Squibb Company | 63.83 -1.05% | +12.6% | 130.35 B | PDUFA Date 2026-08-17 | PDUFA | 78.5% Iberdomide (BMS-986382), developed by Bristol Myers Squibb (BMY), is a cereblon E3 ligase modulator (CELMoD™) that operates by directly inducing tumor cell death and enhancing immune response through CRBN binding. This investigational drug is currently under evaluation for relapsed or refractory multiple myeloma (RRMM), specifically targeting patients who are triple-class refractory. Classified as best-in-class, iberdomide presents a novel mechanism within the immunomodulatory class, demonstrating superior efficacy and tolerability compared to earlier agents such as lenalidomide, particularly in heavily pretreated patient populations. The global market for RRMM is estimated at $12.5 billion, driven by a high prevalence of patients suffering from triple-class refractory disease who currently lack durable treatment options. The unmet need in this space is significant, as existing therapies often result in short progression-free survival (PFS) and high relapse rates among these patients. Iberdomide’s ability to elicit responses in individuals who are refractory to immunomodulators, proteasome inhibitors, and monoclonal antibodies positions it as a crucial therapeutic advancement. Currently, iberdomide is in Phase 3 development for RRMM, with the pivotal trial EXCALIBER-RRMM (NCT04975997) underway. This multicenter, two-stage, randomized, open-label study is comparing iberdomide combined with daratumumab and dexamethasone (IberDd) against daratumumab, bortezomib, and dexamethasone (DVd). The trial has dual-primary endpoints: minimal residual disease (MRD) negativity and progression-free survival (PFS). An interim analysis has shown a statistically significant improvement in MRD negativity rates, a strong surrogate for long-term efficacy. However, the PFS endpoint remains to be fully confirmed, representing a key risk factor. Secondary endpoints include overall survival (OS), overall response rate (ORR), and duration of response (DoR). Efficacy data from earlier trials, such as the Phase 2 I2D study, indicate an ORR of 65% in elderly patients at first relapse, with 36% achieving complete response or very good partial response. In heavily pretreated, triple-class refractory patients, the ORR was approximately 30–50%, demonstrating meaningful clinical activity even in cases resistant to standard therapies. The safety profile has been generally consistent with previous studies, showing manageable adverse events without reaching a maximum tolerated dose in dose-escalation cohorts. Regulatory designations for RRMM include Fast Track, granted to expedite development, Orphan Drug status for rare diseases, and Priority Review, anticipated for the NDA/BLA submission due to the significant benefit expected. The drug is not currently designated as a Breakthrough Therapy or for Accelerated Approval for this indication. The competitive landscape features next-generation BCMA-targeting therapies, but iberdomide’s all-oral regimen and proven efficacy in triple-class refractory disease provide a distinct advantage. Notable precedents include the approval of teclistamab, a BCMA bispecific, and elranatamab, which have shown deep responses but with higher toxicity profiles. Iberdomide’s MRD benefit aligns with historical precedents where MRD negativity has been a strong predictor of approval, as seen with daratumumab combinations. The Probability of Approval (PoA) for iberdomide stands at 78.5%, supported by the statistically significant MRD endpoint, the drug’s established safety profile, and the pressing unmet need within the RRMM population. Although the PFS endpoint remains unconfirmed, the MRD data serves as a robust surrogate that has historically facilitated FDA approvals in myeloma. Key risks include the potential for non-significance in the PFS endpoint and emerging safety signals within the triple-class refractory cohort. Upcoming catalysts include the final PFS analysis and the FDA’s PDUFA decision, anticipated in early 2027. Investors should closely monitor the PFS data release, as it will be a definitive factor in substantiating the drug’s long-term benefit. Read More | ±2.7% | -1.29 M | 4 +49% | PROFITABLE | 11.46 K | 1.11 B | 7.53 M | 2.56% | |||
 TVRDTvardi Therapeutics, Inc. | 1.9 7.34% | -5.5% | 17.82 M | Phase 1 data readout 2026-08-19 | Phase 1 | 9% TTI-109 is an oral small-molecule STAT3 inhibitor developed by Tvardi Therapeutics, designated as the company’s initial development program for ulcerative colitis (UC) on July 30, 2026. Tvardi characterizes TTI-109 as a next-generation STAT3 inhibitor, with its biological rationale rooted in findings from a Phase 1 healthy-volunteer study. This study indicated modulation of STAT3-driven immune cell populations, such as Th17, T follicular helper, and B cells, which are implicated in UC pathology. Given the absence of any approved UC therapies utilizing STAT3 inhibition as a mechanism, TTI-109 is positioned as first-in-class for this indication. The market landscape for UC is compelling, with estimates placing the global market size at approximately $10-15 billion. Despite the availability of various advanced therapies, there remains a significant unmet need. Many patients experience treatment failure, loss of response, or intolerable side effects from existing options, which include anti-TNF agents, integrin blockers, IL-12/23 and IL-23 agents, S1P modulators, and JAK inhibitors. The demand for a therapy that offers both efficacy and improved safety and durability remains strong. Currently, TTI-109 is in the early stages of development. The company has completed a Phase 1 healthy-volunteer study and plans to initiate a clinical trial for moderate-to-severe UC in 2027, pending IND clearance and additional funding. At this time, no NCT number for the UC trial has been publicly disclosed, and there are no patient efficacy results available for this indication. Consequently, metrics such as overall response rate (ORR), progression-free survival (PFS), overall survival (OS), hazard ratios, and p-values are not applicable. The primary endpoint for the planned UC trial will focus on safety, with clinical remission at 12 weeks serving as a secondary endpoint. Safety data from the healthy-volunteer study remain limited. Tvardi has reported no serious adverse events, no discernible dose-dependent patterns of treatment-emergent adverse events (TEAEs), and no clinically significant changes in vital signs or ECGs. However, one subject receiving TTI-109 at a dose of 250 mg BID discontinued due to grade 3 transaminitis, a signal that warrants careful monitoring in a chronic indication like UC. Regarding regulatory designations, the available sources indicate that TTI-109 does not currently hold Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval status for UC. Given that the drug is only being positioned for UC now, all relevant designations should be considered absent. In terms of competitive landscape, recent FDA approvals in UC have typically required clear efficacy data alongside a manageable safety profile. Agents that have demonstrated robust remission and endoscopic data have fared well, while those with safety concerns or insufficient therapeutic benefit have encountered challenges. Given TTI-109’s lack of patient efficacy data at this stage, the program's likelihood of approval is currently assessed as below average, despite its promising mechanism and market potential. A probability of approval (PoA) of 9.0% is deemed a reasonable estimate, primarily influenced by the early development status and the existing uncertainties surrounding safety and efficacy. Key risks associated with TTI-109 include the absence of UC efficacy data, the fact that clinical development has not yet commenced for UC, and uncertainties regarding safety, particularly in light of the transaminitis signal observed in the healthy-volunteer study. Upcoming catalysts include the anticipated IND clearance for the UC study, the initiation of the first moderate-to-severe UC clinical trial in 2027, and updates regarding additional funding, although specific timelines for these events have not been disclosed. Read More | ±53.7% | - | – | CAUTION | 15.77 | 2.21 | 355.81 K | 4.82% | |||
 CAPRCapricor Therapeutics, Inc. | 6.65 54.39% | -70.4% | 385.11 M | PDUFA Date 2026-08-22 | PDUFA | 77% Deramiocel (CAP-1002), developed by Capricor Therapeutics, is an investigational allogeneic cardiosphere-derived cell therapy aimed at treating Duchenne muscular dystrophy (DMD). This therapy is positioned as a first-in-class treatment, targeting both skeletal muscle weakness and cardiac complications associated with DMD, addressing a significant unmet medical need. Unlike existing therapies that primarily focus on skeletal manifestations, deramiocel's dual mechanism offers the potential for transformative benefits if approved. Currently, deramiocel is undergoing regulatory review, with its Biologics License Application (BLA) under the FDA's Priority Review process. The target action date for the FDA's decision is set for August 22, 2026. The Phase 3 HOPE-3 trial, which is pivotal for the drug's approval, enrolled 106 boys with DMD, both ambulatory and non-ambulatory. This trial employed a randomized, double-blind, placebo-controlled design, administering four doses over a 12-month period. The primary endpoint focused on the mean change from baseline in upper limb function, assessed by the Performance of the Upper Limb test, version 2.0 (PUL 2.0) Total Score at 12 months. Additionally, the trial evaluated several secondary endpoints, including cardiac muscle function via cardiac magnetic resonance imaging (cMRI), hand-to-mouth function, quality of life assessments, and biomarker analysis. The HOPE-3 trial successfully achieved its primary endpoint and all Type I error-controlled secondary endpoints, with the results described as "positive pivotal." While specific efficacy metrics such as odds ratios, hazard ratios, and p-values are not disclosed, the data support the notion of musculoskeletal and cardiac benefits. The safety profile of deramiocel is characterized as consistent across long-term follow-up, although detailed adverse event rates from the trial are not publicly available. In terms of market positioning, the global market size for DMD therapeutics is not specified, but the unmet medical need is significant. Deramiocel is uniquely positioned as potentially the first therapy to address both skeletal and cardiac manifestations of DMD, indicating a substantial gap in current treatment options. This first-in-class classification highlights its innovative approach to addressing the complexities of the disease. The competitive landscape for deramiocel includes existing therapies that primarily target either skeletal muscle or cardiac issues separately. As such, deramiocel's ability to address both aspects may provide a competitive advantage. However, the search results do not offer detailed insights into the competitive pipeline or market size for DMD therapeutics. Despite the promising data, there are key risks associated with deramiocel's approval. The program previously received a Complete Response Letter from the FDA, indicating unresolved regulatory questions. While Capricor's response has been acknowledged, there remains uncertainty regarding whether the FDA's concerns have been fully addressed. Additionally, while the HOPE-3 trial met its endpoints, the clinical significance of the observed improvements, particularly in cardiac function, and their translation into meaningful patient outcomes require careful evaluation by the FDA. Furthermore, as an allogeneic cell therapy, deramiocel faces inherent challenges related to manufacturing consistency, scalability, and cost-effectiveness, which could impact regulatory approval or post-approval requirements. The estimated Probability of Approval (PoA) for deramiocel is 72–82%. This range reflects the positive Phase 3 efficacy data and the Priority Review designation, which are significant favorable factors. However, the prior Complete Response Letter introduces meaningful uncertainty, as the FDA's specific concerns and whether they have been adequately resolved remain unclear from public disclosures. The limited publicly available efficacy data also creates ambiguity regarding the magnitude of clinical benefit that the FDA will deem sufficient. An approval decision is anticipated by August 22, 2026. Read More | ±61.5% | -4.08 M | 9 +31% | STABLE | 237.93 | 14.31 | 66.33 M | 38.47% | |||
 SVRASavara, Inc. | 5.38 2.09% | -13.2% | 1.10 B | PDUFA Date 2026-08-22 | MOLBREEVI (molgramostim inhalation solution) autoimmune pulmonary alveolar proteinosis (autoimmune PAP) | PDUFA | 81.5% MOLBREEVI (molgramostim) is an inhaled recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) developed by Savara Inc. (SVRA) for the treatment of autoimmune pulmonary alveolar proteinosis (autoimmune PAP), a rare and debilitating lung disease characterized by pathological surfactant accumulation. The drug is currently under review by the FDA following the resubmission of its biologics license application (BLA), which includes a request for priority review. The market for autoimmune PAP presents a significant unmet medical need, as there are currently no approved pharmacologic therapies in the U.S. or Europe. The disease is driven by autoantibodies against endogenous GM-CSF, which hinder alveolar macrophages from clearing surfactant, leading to progressive hypoxemia, impaired gas exchange, and potentially fatal complications, including lung fibrosis and the need for transplantation. The only established treatment at present is whole lung lavage, an invasive mechanical procedure, underscoring the necessity for a pharmacologic alternative. MOLBREEVI is positioned as a first-in-class therapy, with no competing drugs utilizing the same mechanism for this indication. The clinical evidence supporting MOLBREEVI stems from the Phase 3 IMPALA-2 trial (NCT04544293), a randomized, double-blind, placebo-controlled study that enrolled 164 patients across 43 sites in 16 countries. Participants received either 300 μg of molgramostim or placebo once daily via inhaled nebulizer for 48 weeks, followed by a 96-week open-label extension. The trial demonstrated statistically significant improvements in the primary endpoint of pulmonary gas transfer (DLco adjusted for hemoglobin) compared to placebo at week 24. Notably, IMPALA-2 was the first trial in autoimmune PAP to show enhancements in patient functionality, evidenced by a 0.6 MET difference in exercise capacity at week 48 (molgramostim 1.1 MET vs. placebo 0.6 MET; 95% CI, 0.1-1.0), alongside improvements in respiratory quality of life and surfactant burden. Importantly, no notable safety concerns were reported, and the extended follow-up provides robust safety data that exceeds typical Phase 3 requirements. Results were published in the New England Journal of Medicine in August 2025, offering peer-reviewed validation of the findings. Regulatory designations strongly support the drug's approval potential. MOLBREEVI has received Fast Track, Breakthrough Therapy, and Orphan Drug designations from the FDA, as well as Orphan Drug and Promising Innovative Medicine designations from the EMA and UK MHRA. The resubmitted BLA carries a priority review request, indicating the FDA's recognition of the program's clinical importance. These designations collectively signal the FDA's agreement that MOLBREEVI addresses a serious unmet medical need with potential clinical advantages, thereby reducing regulatory risk. However, the BLA resubmission indicates initial deficiencies identified by the FDA, likely related to manufacturing, chemistry, or labeling issues rather than efficacy or safety concerns. While such deficiencies are typically resolvable, they introduce uncertainty regarding approval timing and potential post-marketing requirements. Additionally, although the efficacy improvements are statistically significant and clinically meaningful, the magnitude of benefit—particularly the 0.6 MET exercise capacity improvement—is modest rather than transformative, which could influence the FDA's final decision. The competitive landscape is favorable, as no approved therapies exist for autoimmune PAP, eliminating concerns about head-to-head comparisons. The rare disease designation, estimated to encompass 1,000-2,000 patients globally, reduces regulatory burden and facilitates approval pathways. Nonetheless, the FDA's recent approach to rare disease approvals has become more stringent, and the agency may request additional post-marketing studies or impose restrictions. The estimated probability of approval for MOLBREEVI is 78-85%. This range reflects strong clinical data, robust regulatory support, first-in-class positioning, and significant unmet medical need, tempered by manufacturing deficiencies requiring BLA resubmission, modest effect sizes, and uncertainties surrounding regulatory precedents. While approval is more likely than not, the resubmission requirement and evolving FDA standards introduce meaningful risk. The priority review designation and breakthrough therapy status suggest that the FDA is motivated to resolve outstanding issues expeditiously, supporting the higher end of this range. Read More | ±15.1% | -6.51 M | 12 0% | STABLE | 173.03 | 13.65 | 1.65 M | 25.14% |
• FAQs
Frequently asked questions about the FDA calendar
A PDUFA date is the deadline by which the FDA aims to complete its review of a new drug or biologic application and issue a decision. The name comes from the Prescription Drug User Fee Act, the law that lets the FDA collect fees from drug makers in exchange for committing to these review timelines. On or before the PDUFA date the FDA will approve the drug, issue a Complete Response Letter, or otherwise act on the application. Because these dates are binary events, they are among the most watched catalysts for biotech stocks, and upcoming ones are listed on the calendar above.
The calendar above can be sorted by date so you can see decisions expected in the current week or over the next five trading days, including small-cap biotech catalysts. Recently issued approvals and Complete Response Letters are listed alongside upcoming dates, so you can review both what just happened and what is coming next. Because the FDA can act a few days before a listed PDUFA date, it is worth watching the days leading up to each event, not just the date itself.
No. The FDA does not publish a public, forward-looking calendar of pending PDUFA dates, because confidentiality rules (21 CFR 314.430) generally bar it from confirming that an application even exists until the sponsor makes it public. The PDUFA dates you see in calendars come from the drug companies themselves, who disclose expected action dates in press releases and SEC filings, and from aggregators that compile and verify them. The calendar on this page is one such aggregated, regularly updated source.
A Complete Response Letter is the FDA's way of telling a drug company that its application cannot be approved in its current form. The letter spells out the deficiencies the company must address, which can range from manufacturing and labeling issues to questions about safety or effectiveness. A CRL is not a permanent rejection: the sponsor can fix the problems and resubmit, which starts a new review cycle and a new PDUFA date. CRLs often trigger sharp stock declines because they delay or jeopardize a product launch.
An Advisory Committee, or AdCom, is a panel of outside experts the FDA convenes to review a drug's data and vote on questions about its safety and efficacy. The vote is non-binding, but the FDA usually follows the panel's recommendation, so the outcome is a major catalyst. AdComs typically take place several months before the PDUFA date and can move a stock sharply in either direction on the day of the vote. Scheduled AdCom dates appear alongside PDUFA dates on the calendar above.
A New Drug Application (NDA) is the submission used to seek approval for small-molecule, chemically synthesized drugs, while a Biologics License Application (BLA) covers biologics such as antibodies, vaccines, and cell and gene therapies. Both are reviewed under the same PDUFA timelines and both result in either approval or a Complete Response Letter. The distinction matters because biologics follow a separate regulatory pathway and have different exclusivity rules.
After Phase 3 trials finish, a company typically needs 6 to 12 months to compile and submit the New Drug Application (NDA) or Biologics License Application (BLA). The FDA then takes about 60 days to decide whether to accept the filing, after which the formal review clock runs 10 months for a standard review or 6 months for a priority review. In total, the path from Phase 3 completion to an FDA decision often spans roughly a year and a half to two years, though it varies widely by program and review type. Each application's specific PDUFA decision date appears on the calendar above once it is set.