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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 Nov 14, 2026
Showing 11 Catalysts Out Of 1292. Click On The Tickers For More Details
| Company | Price | 30-Day Trend | Market Cap | Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Expected Move | Insiders | Hedge Funds | Risk | Cash | Burn Rate | Volume | Float Short | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 CYTKCytokinetics, Incorporated | 56.13 -0.05% | -14.4% | 7.82 B | PDUFA Date 2026-11-14 | sNDA | 99% As of May 13, 2026, MYQORZO (aficamten) has already received FDA approval on December 19, 2025, and is commercially available in the United States as of January 27, 2026. Additionally, it has secured European Commission approval on February 17, 2026. Given this context, a traditional Probability of Approval (PoA) analysis is not applicable; however, a retrospective examination of the approval pathway and current regulatory status is warranted. MYQORZO is currently approved and commercialized, having undergone a pivotal Phase 3 trial known as SEQUOIA-HCM, which was a randomized, placebo-controlled study involving 282 adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) over a 24-week treatment period. The primary endpoint focused on exercise capacity, specifically peak oxygen uptake (pVO₂) measured through cardiopulmonary exercise testing. The results were compelling, with the MYQORZO group demonstrating a statistically significant increase in pVO₂ of 1.76 mL/kg/min from baseline, compared to no change in the placebo group (p=0.000002). Secondary endpoints also showed favorable outcomes, with 59% of MYQORZO patients experiencing improvement in New York Heart Association (NYHA) functional class compared to 24% in the placebo group. The safety profile of MYQORZO, as noted in FDA documentation, indicates a risk of reduced heart muscle contraction potentially leading to heart failure, necessitating careful monitoring. While specific adverse event rates were not detailed, no major safety signals emerged as barriers to approval. The drug is designed for reversibility and predictable exposure-response, suggesting a favorable safety profile. MYQORZO has received several regulatory designations for HCM, including Breakthrough Therapy Designation and Priority Review, reflecting the FDA's recognition of the significant unmet medical need in symptomatic obstructive HCM. Notably, while HCM is classified as a rare disease, it lacks Orphan Drug Designation. The market opportunity for MYQORZO is substantial, with an estimated global market size of $2.5–4.0 billion in 2026. The unmet need is significant, as prior treatment options have been limited to symptomatic management or invasive therapies, with MYQORZO representing the first oral, non-invasive, disease-modifying therapy targeting the underlying hypercontractility of the condition. In terms of competitive positioning, MYQORZO stands out as a first-in-class therapy with a unique mechanism of action as an allosteric, reversible cardiac myosin inhibitor. This mechanism differentiates it from existing treatments, which primarily focus on symptomatic relief. The competitive landscape includes traditional therapies such as beta-blockers and calcium channel blockers, as well as invasive septal reduction therapies. Notably, MYQORZO has succeeded where mavacamten, another myosin inhibitor, failed in the EXPLORER-HCM trial, which has raised regulatory concerns about the class. Cytokinetics, the developer of MYQORZO, has a strong track record in cardiac drug development, having previously secured FDA approval for omecamtiv mecarbil in April 2023. This history enhances confidence in the company's ability to navigate regulatory pathways effectively. While MYQORZO's approval marks a significant milestone, several risks remain. These include the potential for heart failure exacerbation, limited market penetration due to the rarity of HCM, competitive pressures from emerging therapies, reimbursement challenges, and the need for long-term safety data beyond the initial trial period. Upcoming catalysts include long-term follow-up data from SEQUOIA-HCM extension studies and potential label expansions. In conclusion, MYQORZO represents a groundbreaking advancement in the treatment of symptomatic obstructive HCM, addressing a critical unmet need with its novel mechanism and favorable efficacy profile. The drug's approval and commercialization signify a pivotal moment for Cytokinetics, positioning it as a leader in this emerging therapeutic category. The estimated Probability of Approval for MYQORZO stands at 100%, reflecting its successful regulatory journey and market entry. Read More | ±2.4% | -13.00 M | 13 -22% | HEALTHY | 1.58 B | 41.34 M | 1.01 M | 13.34% | |||
 SMMTSummit Therapeutics Inc. | 14.15 -6.14% | -10.0% | 11.32 B | PDUFA Date 2026-11-14 | ivonescimab (SMT112/AK112) EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer previously treated with a third-generation EGFR TKI | PDUFA | 62% Ivonescimab (SMT112/AK112) is an investigational bispecific antibody developed by Summit Therapeutics, targeting PD-1 and VEGF to integrate immune checkpoint inhibition with anti-angiogenic activity. This drug is specifically indicated for patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR TKI. Currently, the program has advanced to the U.S. New Drug Application (NDA)/Biologics License Application (BLA) stage, having submitted its BLA in January 2026. The FDA has accepted this application for filing and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 14, 2026. The pivotal evidence for ivonescimab comes from the HARMONi trial, a multiregional, randomized, double-blinded, placebo-controlled phase III study. This trial compared ivonescimab combined with platinum-doublet chemotherapy against a placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated NSCLC who had previously progressed on a third-generation EGFR TKI. The study design and patient population align closely with the intended label for ivonescimab. Summit Therapeutics reported that HARMONi met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with a hazard ratio of 0.52 (95% CI 0.41-0.66, p<0.00001). However, details regarding overall survival and objective response rates remain less complete in the available sources. Safety profiles have been characterized as manageable, with no new safety signals reported, although the combination of chemotherapy raises concerns about potential hematologic toxicity, infusion reactions, and immune-related adverse events. The market for this indication is notably underserved. After the failure of osimertinib or other third-generation EGFR TKIs, patients typically receive platinum-based chemotherapy, which often yields limited benefits due to complex resistance biology. This scenario underscores a significant unmet need. Ivonescimab is classified as first-in-class, as it uniquely combines PD-1 and VEGF blockade in a single bispecific antibody for this indication, distinguishing it from existing therapies. While the program must contend with established chemotherapy standards and a competitive pipeline of post-osimertinib strategies, its robust randomized phase III PFS results and the relevant trial population represent considerable advantages. Key risks associated with the approval of ivonescimab include the FDA's potential concerns regarding the strength of the data, particularly in relation to overall survival and safety in a highly competitive post-TKI environment. The regulatory landscape is further complicated by the fact that approval is based on a single global phase III dataset, with limited precedents in this specific setting. Although the program has received Fast Track designation for this post-EGFR TKI NSCLC indication, it lacks Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations. Upcoming catalysts include the FDA's PDUFA action date on November 14, 2026, and potential regulatory decisions in China or other regional label expansions, although specific timelines for these events have not been disclosed. The estimated probability of approval (PoA) stands at 62.0%, reflecting a greater-than-even chance of success, albeit not a guarantee. The FDA's evaluation will likely focus on whether PFS data alone is sufficient, the robustness of overall survival and safety data, and the comparative benefit against existing salvage therapies. Read More | ±10.6% | - | 5 +1% | CAUTION | 629.79 M | 53.27 M | 5.56 M | 27.76% | ||
 NVONovo Nordisk A/S | 41.63 2.41% | +8.9% | 185.88 B | Phase 3 data presentation 2026-11-14 | Phase 3 | 42% Semaglutide, a once-weekly subcutaneous GLP-1 receptor agonist developed by Novo Nordisk, is designed to reduce appetite, increase satiety, and lower body weight through both central and peripheral GLP-1 signaling. While semaglutide has already established its efficacy in treating obesity in adults and adolescents, there remains a significant unmet medical need for children aged 6 to under 12 years, as no medication has been approved for nonsyndromic obesity in this age group. The global market for pediatric obesity is estimated to be around $15 billion, highlighting the substantial long-term potential for a successful therapy in this demographic. Semaglutide is classified as best-in-class rather than first-in-class, as the GLP-1 biology has already been clinically validated through other agents like liraglutide. The differentiation of semaglutide is expected to stem from its superior weight-loss efficacy and the convenience of once-weekly dosing, rather than from a novel mechanism of action. Currently, Novo Nordisk's pediatric obesity development program is in Phase 3, featuring a randomized, placebo-controlled trial that includes lifestyle intervention as background therapy. The trial aims to demonstrate superiority over placebo while assessing BMI reduction and safety over an extended follow-up period. However, as of the date of this analysis, no completed efficacy data for this specific age group has been publicly reported. The existing evidence of semaglutide's efficacy in adolescents bolsters the biological plausibility of its use in younger children, yet it does not replace the necessity for direct evidence in this population. Regulatory designations for semaglutide in treating obesity in children aged 6 to under 12 years are notably lacking. There is no public evidence supporting Fast Track, Breakthrough Therapy, Orphan Drug, Priority Review, or Accelerated Approval for this indication. The absence of special regulatory status may modestly lower the probability of approval, which is currently assessed at 42.0%. Safety remains a critical concern, particularly given the potential for gastrointestinal side effects such as nausea, vomiting, diarrhea, and abdominal pain. In younger children, regulatory bodies are likely to scrutinize the drug's impact on growth, pubertal development, nutrition, and long-term tolerability. The precedent set by Novo Nordisk’s liraglutide pediatric obesity program, which demonstrated clinically meaningful BMI reduction but also notable gastrointestinal adverse effects, highlights both the potential and the tolerability constraints of the incretin approach. Additionally, while semaglutide has shown strong efficacy in adolescents with a safety profile consistent with class effects, the lack of approval for any GLP-1 obesity drug in children under 12 indicates that the FDA's standards for this age group remain stringent. Novo Nordisk's extensive experience with GLP-1 regulatory submissions and its strong track record of approvals lend support to the program. However, the specific indication for pediatric obesity in children under 12 years is still data-limited. The resulting probability of approval reflects a balanced perspective, taking into account the strong mechanistic rationale and the sponsor's expertise, while also acknowledging the absence of public efficacy data for this age group, the lack of special FDA designations, and the significant safety and regulatory uncertainties that remain. Read More | ±1% | - | 2 +51% | — | - | - | 11.71 M | 1.14% | |||
 RYTMRhythm Pharmaceuticals, Inc. | 115.02 4.70% | +18.3% | 7.88 B | Phase 3 data presentation 2026-11-14 | Phase 3 | 99% IMCIVREE (setmelanotide), developed by Rhythm Pharmaceuticals (RYTM), is a daily injectable melanocortin-4 receptor (MC4R) agonist aimed at restoring downstream melanocortin signaling to mitigate pathological hunger and excess body weight. Specifically targeting acquired hypothalamic obesity, the program has transitioned beyond Phase 3 classification, as the FDA granted approval for this indication on March 19, 2026, for both adults and children aged four years and older. As of November 3, 2026, the estimated probability of approval stands at 99.9%, reflecting the successful completion of the regulatory process rather than a prospective evaluation. The pivotal development program, RM-493-040, was a multicenter Phase 3, randomized, double-blind, placebo-controlled trial that enrolled 120 participants, including both adults and pediatric patients with acquired hypothalamic obesity. Participants received either once-daily setmelanotide or a placebo for approximately 52 weeks. The primary endpoint demonstrated a placebo-adjusted BMI reduction of approximately 19.8%. While the available evidence does not provide a comprehensive peer-reviewed dataset, including full responder rates and confidence intervals, the efficacy signal observed was significant for this rare obesity disorder and appears to have supported the regulatory approval. The safety profile associated with setmelanotide aligns with the known effects of MC4R agonism, including nausea, vomiting, headache, injection-site reactions, fatigue, skin hyperpigmentation, and sexual adverse effects. Given the small size of the pivotal population and the clinical heterogeneity of acquired hypothalamic obesity, long-term monitoring of safety is essential. Although no new fatal or irreversible safety signals have been established, post-marketing exposure will be considerably larger than that of the trial population. Regarding regulatory designations, it is important to distinguish the acquired-hypothalamic-obesity designation from those granted for other setmelanotide programs. The evidence confirms orphan designation in the United Kingdom and Japan, while FDA documentation supports the acquired-obesity supplement and approval. However, there is no reliable evidence indicating a U.S. Fast Track or Breakthrough Therapy designation specifically for acquired hypothalamic obesity; the previously mentioned Breakthrough Therapy designation pertains to an earlier context of setmelanotide development. Priority review has been granted for the approved supplement, while accelerated approval is not supported by the reviewed evidence. The addressable market for IMCIVREE is unlikely to reach the multibillion-dollar figures associated with common obesity. A defensible estimate positions it within a sub-$1 billion global orphan market, although public sources do not provide a validated dollar figure. The unmet need is substantial, as hypothalamic injury can lead to severe hyperphagia and weight gain that are resistant to lifestyle interventions and standard obesity treatments. Setmelanotide is classified as first-in-class for this indication, as no other approved therapy directly addresses MC4R-pathway activity in acquired hypothalamic obesity. Competitive pressures primarily arise from off-label GLP-1 therapies, bariatric procedures, and investigational approaches, rather than from an approved mechanism-specific competitor. Previous approvals of setmelanotide in genetically defined obesity have established both the mechanism and safety framework, and the regulatory acceptance of orphan obesity indications despite small studies lends credibility to Rhythm's execution capabilities. However, the company remains reliant on this principal commercial asset, raising critical investment questions regarding market access, treatment durability, real-world tolerability, and potential expansion beyond the rare acquired-obesity population, rather than concerns about U.S. approval risk. Read More | ±4.5% | -13.53 M | 10 -1% | HEALTHY | 320.94 M | 1.02 M | 1.16 M | 17.53% | |||
 MTVAMetaVia Inc. | 1.3 0.00% | -15.6% | 8.56 M | Phase 1 data presentation 2026-11-14 | Phase 1 | 8% DA-1726 is a novel therapeutic candidate developed by MetaVia, designed as a once-weekly, subcutaneous oxyntomodulin analogue that acts as a dual GLP-1 receptor and glucagon receptor agonist. This innovative molecule employs a potency ratio of approximately 3:1 for GLP-1 receptor to glucagon receptor, aiming to harness the appetite suppression and glucose control benefits of GLP-1 while also promoting energy expenditure and fat mobilization through glucagon. As a result, DA-1726 is classified as first-in-class, particularly due to its unique engineered dual-agonist profile, although it faces competition from a range of GLP-1-based and other multi-receptor metabolic therapies. The market potential for DA-1726 is significant, given the large populations affected by MetALD and ALD, which are associated with considerable unmet medical needs. The company estimates that approximately 10.7 million adults in the U.S. are living with MetALD, with an addressable population of 35–60 million across major markets, including the U.S., EU4, UK, Japan, and China. However, a reliable indication-specific dollar estimate for the market has not been established, as it would require assumptions regarding future pricing, treated populations, and market penetration rates. Therefore, any fabricated revenue figure would be misleading. Currently, the estimated probability of approval (PoA) for DA-1726 stands at 8.0%. This figure reflects the likelihood of regulatory approval for MetALD and/or ALD, rather than merely the advancement of the drug into Phase 2 trials. The low PoA is attributed to the program's early clinical stage, which includes very small studies conducted on healthy volunteers rather than patients with MetALD or ALD, as well as the absence of efficacy data in the target disease population and the historical attrition rates of metabolic and liver disease programs. The key risks associated with DA-1726 include several factors. First, the early-stage evidence is limited, as the drug remains in Phase 1, with principal results derived from studies involving obese but otherwise healthy adults. Second, the benefits of reducing liver fat have not yet been demonstrated in terms of improving steatohepatitis, fibrosis, cirrhosis progression, liver-related events, or overall survival. Third, there are safety concerns related to GLP-1/glucagon agonism, which may lead to gastrointestinal adverse effects, treatment discontinuation, gallbladder events, pancreatitis, heart-rate effects, and tolerability issues during dose escalation. Additionally, regulatory endpoint uncertainty exists, as a non-biopsy Phase 2 study may support proof of concept but may not suffice for full approval without validated histologic or clinical outcome evidence. Finally, competitive pressure from other GLP-1, GLP-1/GIP, GLP-1/glucagon, FGF21, and other liver-directed programs could potentially establish stronger efficacy or safety profiles before DA-1726 reaches registration trials. Looking ahead, several upcoming catalysts could impact the program's trajectory. The company anticipates reporting topline data from Phase 1 Parts 3A and 3B in the first quarter of 2027, with plans to initiate a Phase 2 study in MetALD and ALD in the second half of 2027. This Phase 2 study is expected to be a 48-week, non-biopsy trial involving up to 150 subjects, although this remains a planned initiative rather than a completed regulatory milestone. In summary, while DA-1726 presents a clinically meaningful opportunity in addressing the unmet needs of MetALD and ALD, the program's current status in Phase 1, the absence of disease-specific efficacy data, and the competitive landscape contribute to an 8.0% probability of eventual approval. The forthcoming topline readout in Q1 2027 and the proposed Phase 2 study initiation later that year will be critical milestones to monitor as the program progresses. Read More | ±5.2% | - | – | CAUTION | 8.78 M | 1.24 M | 50.19 K | 1.18% | |||
 MBXMBX Biosciences, Inc. | 55.94 2.62% | -6.8% | 2.69 B | Pre-clinical data presentation 2026-11-14 | Pre-clinical | 3% MBX 6180 is a preclinical candidate developed by MBX Biosciences, targeting obesity through a novel mechanism as a GLP-1/GIP/glucagon (GCG) triple-agonist prodrug. The drug aims to activate three metabolically relevant pathways within a single molecule, leveraging MBX’s prodrug technology to potentially allow for once-monthly administration. However, as it currently stands, MBX 6180 is firmly in the preclinical stage, with no human safety, pharmacokinetic, pharmacodynamic, or efficacy data reported to date. The global obesity market is projected to reach approximately $18 billion in 2024, with significant growth anticipated. Despite the presence of successful incretin therapies, the unmet need in this space remains substantial. Obesity is a chronic condition that is often undertreated, with current therapies facing challenges such as frequent dosing, tolerability issues, access constraints, high costs, and the risk of weight regain after discontinuation. MBX 6180 is mechanistically differentiated as a triple agonist; however, it is not considered first-in-class due to the existence of other GLP-1/GIP/glucagon triple agonists already in development. Thus, it is best characterized as a me-too or next-generation entrant until clinical data can demonstrate meaningful superiority. In terms of regulatory designations, MBX 6180 does not currently possess any obesity-specific FDA designations or review pathways. The absence of an Investigational New Drug (IND) application, New Drug Application (NDA), or Biologics License Application (BLA) means that Priority Review and Accelerated Approval are not applicable at this stage. The estimated probability of approval (PoA) for MBX 6180 stands at 3.0%. This figure reflects the likelihood of approval from the current preclinical stage to obesity approval, rather than the probability of success after an IND or following Phase 1 trials. A reasonable uncertainty range for this estimate is approximately 1–7%. Key risks associated with MBX 6180 include the lack of reported human data, which raises concerns about safety and efficacy. The triple agonism of GLP-1/GIP/GCG may lead to gastrointestinal intolerance, excessive weight loss, dehydration, gallbladder events, and other dose-limiting toxicities. Additionally, the challenges associated with once-monthly exposure and prodrug activation may complicate dose control and adjustment. The competitive landscape for obesity treatments is intense, with established weekly incretin products and numerous oral, long-acting, and multi-agonist programs vying for market share. Furthermore, MBX has yet to demonstrate a successful product approval, with its lead program remaining in development. Upcoming catalysts include a presentation of preclinical pharmacokinetic data at ObesityWeek 2026, scheduled for November 14–17, 2026, in Washington, D.C. The company has indicated that MBX 6180 data will be presented at this meeting. Additionally, IND-enabling studies are currently underway, although the timing for these studies and the subsequent IND submission and first-in-human study has not been disclosed. In summary, while MBX 6180 represents a potentially innovative approach to obesity treatment, it is currently classified as a me-too candidate, lacking the clinical evidence necessary to claim first-in-class or best-in-class status. The absence of regulatory designations and the competitive nature of the obesity market further complicate its positioning. The 3.0% probability of approval reflects the high attrition rates typical of preclinical obesity programs, the absence of human data, and the uncertain tolerability of the triple-agonist approach. Positive pharmacokinetic data and a well-tolerated first-in-human study could enhance this estimate, while challenges in establishing controllable exposure or acceptable tolerability could significantly diminish it. Read More | ±3.7% | -288.36 K | 14 +5% | HEALTHY | 481.59 M | 11.63 M | 855.45 K | 13.63% | |||
 OGNOrganon & Co. | 13.9 0.00% | +1.3% | 3.65 B | Phase 3 data presentation 2026-11-14 | Phase 3 | - | – | PROFITABLE | 1.46 B | - | 4.00 M | 7.55% | |||||
 PHVSPharvaris N.V. | 33.36 -1.39% | +8.5% | 2.34 B | Phase 3 data presentation 2026-11-14 | Phase 3 | -34.17 M | 10 +6% | — | - | - | 182.64 K | 7.52% | |||||
 TEVATeva Pharmaceutical Industries Limited | 44.5 1.95% | +10.4% | 51.92 B | PDUFA Date 2026-11-14 | IGALMI® (dexmedetomidine) Acute treatment of agitation associated with bipolar disorders, schizophrenia Fast Track | sNDA | -40.19 M | 3 -50% | PROFITABLE | 4.08 B | - | 7.56 M | 2.5% | ||||
 AMLXAmylyx Pharmaceuticals, Inc. | 30.29 1.44% | +7.4% | 3.38 B | Phase 3 data presentation 2026-11-15 | avexitide Post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery BreakthroughOrphan | Phase 3 | -11.40 M | 11 -5% | HEALTHY | 768.13 M | 11.22 M | 1.62 M | 11.78% | ||||
 WVEWave Life Sciences Ltd. | 3.13 -0.79% | -16.5% | 617.33 M | Phase 1 interim results 2026-11-15 | Phase 1 | - | 6 -7% | STABLE | 431.01 M | 20.05 M | 2.66 M | 12.49% |
• 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.