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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 Sep 30, 2026
Showing 11 Catalysts Out Of 1266. 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 ORKAOruka Therapeutics, Inc. | 82.15 -3.79% | -27.4% | 5.44 B | Phase 2a data readout 2026-09-30 | Phase 2a | 74% ORKA-001 is a long-acting anti-IL-23p19 monoclonal antibody developed by Oruka Therapeutics for the treatment of moderate-to-severe plaque psoriasis. This drug is strategically positioned as a convenience-optimized biologic rather than a novel pathway drug. Currently, ORKA-001 is in Phase 2a clinical development, with the pivotal study identified as EVERLAST-A (NCT07090330). This randomized, double-blind, placebo-controlled trial involves adults with moderate-to-severe plaque psoriasis, enrolling 84 patients who were randomized in a 3:1 ratio to receive either ORKA-001 or a placebo. The study design includes a single induction dose level for the primary Phase 2a readout, followed by re-randomization among responders to investigate extended maintenance intervals. Additionally, an open-label extension study (NCT07449702) is assessing long-term safety and durability, while an earlier Phase 1 study (NCT06698939) focused on dose selection and pharmacokinetic characterization. The efficacy data available thus far are promising for a mid-stage psoriasis study. Oruka reported that 40 out of 63 treated participants, or 63.5%, achieved a Psoriasis Area and Severity Index (PASI) 100 at Week 16. Secondary endpoints also demonstrated strong results, with 83% of treated participants achieving PASI 90 and 84% achieving an Investigator's Global Assessment (IGA) score of 0/1. In contrast, the placebo group showed significantly lower efficacy, with only about 4.8% of patients achieving complete clearance. While no mature progression-free survival or overall survival metrics are applicable to this dermatology program, safety signals have not been raised in the available public updates. However, the dataset remains relatively small, and follow-up is limited, making class-consistent biologic tolerability, infection risk, immunogenicity, and durability of response critical factors to monitor. In terms of regulatory designations, there is currently no public evidence supporting Fast Track, Breakthrough Therapy, Orphan Drug, Priority Review, or Accelerated Approval designations for moderate-to-severe psoriasis. Given the commonality of the indication, orphan status is not feasible, and no accelerated path is apparent from the available disclosures. The psoriasis market is substantial, with global estimates exceeding $20 billion. Despite the presence of multiple effective biologics, there remains an unmet need as many patients seek deeper skin clearance, less frequent injections, and more durable remission. ORKA-001 is classified as best-in-class rather than first-in-class or me-too, leveraging a validated IL-23p19 mechanism already established by approved therapies. Its differentiation lies in the significantly longer dosing interval and enhanced convenience. The competitive landscape is robust, with established leaders such as risankizumab, guselkumab, and tildrakizumab setting high standards for efficacy and safety. ORKA-001’s primary advantage is not a novel mechanism but the potential for improved durability and dosing convenience. Historical precedents indicate that well-executed psoriasis biologics with strong PASI 100 data typically have a favorable approval trajectory. However, late-stage success will depend on the ability to maintain efficacy, safety, and manufacturability through Phase 3 trials. The estimated Probability of Approval (PoA) stands at 74.0%, which is justified given the validated target biology, compelling early efficacy data, and familiarity with the mechanism. The primary risk lies not in the efficacy of IL-23 blockade but in ORKA-001's ability to sustain its mid-stage profile at scale and sufficiently outperform existing competitors to warrant a differentiated label. Read More | ±21.2% | -29.01 M | 14 +14% | HEALTHY | 1.13 B | 11.05 M | 1.36 M | 12.97% | |||
 NGENNervGen Pharma Corp. | 1.92 5.85% | +12.3% | 206.44 M | Phase 1b/2a data presentation 2026-09-30 | Phase 1b/2a | 18% NVG-291 is NervGen Pharma’s lead neuroreparative peptide targeting spinal cord injury (SCI), traded under the ticker NGEN. This first-in-class investigational peptide aims to promote axonal regeneration and functional recovery in SCI by inhibiting the protein tyrosine phosphatase sigma (PTPσ) pathway, which is designed to alleviate a biological barrier to nervous system repair. While NervGen describes NVG-291 as potentially first- and best-in-class, its classification as first-in-class for chronic cervical SCI is defensible due to the absence of any approved disease-modifying therapies with a similar mechanism. The program has progressed beyond Phase 1b/2a and is now preparing for a registrational Phase 3 study named RESTORE, indicating significant advancement from exploratory development. The pivotal clinical study, CONNECT SCI, is a double-blind, placebo-controlled Phase 1b/2a trial registered under NCT05965700. This trial enrolled adults with cervical motor incomplete SCI across two cohorts: chronic (1–10 years post-injury) and subacute. The trial was designed to be randomized and placebo-controlled, targeting an enrollment of 20 subjects in the chronic cohort. The primary endpoint focused on corticospinal connectivity, assessed through changes in motor evoked potential amplitude, while secondary endpoints included motor function, upper-extremity dexterity and grasping, mobility, electrophysiology, MRI, and blood biomarkers. Preliminary public summaries indicate positive topline data for the chronic cohort, suggesting motor recovery; however, detailed peer-reviewed efficacy metrics such as hazard ratios, p-values, or confidence intervals have not been disclosed, leaving the evidence incomplete for a comprehensive statistical evaluation. Safety data thus far appears favorable, with no major adverse signals reported in the public disclosures. However, the limited sample size and short follow-up duration in early-phase studies mean that the safety database remains insufficient to rule out rare adverse events or tolerability issues. For chronic cervical SCI, the public record supports the Fast Track designation from the FDA, although no evidence has been identified for orphan drug, breakthrough therapy, priority review, or accelerated approval specific to this indication. While Fast Track designation aids development, it does not significantly mitigate the risks associated with approval. The market opportunity for NVG-291 is substantial, as chronic cervical SCI is associated with severe lifelong disabilities and lacks any approved restorative therapies, highlighting a significant unmet need. Competitive pressure in the disease-modifying space is currently limited; however, rehabilitation, neuromodulation, stem-cell approaches, and other neurorestorative programs may emerge as future competitors. The primary challenge for approval will be whether the Phase 3 trial can demonstrate meaningful functional improvements on clinically relevant endpoints within a heterogeneous patient population. Historical trends in neurology and SCI suggest that the FDA tends to favor therapies that exhibit robust, reproducible effects on endpoints and a clear benefit-risk profile. Many failed programs in SCI have encountered difficulties due to weak efficacy, endpoint variability, or insufficient validation in larger studies, warranting a cautious approach. In summary, while NVG-291 presents a scientifically promising profile with a differentiated mechanism and a clear unmet need, the estimated probability of approval remains modest at 18.0%. This reflects the early-stage evidence, inherent endpoint risks, and the complexities involved in demonstrating disease modification in chronic SCI. Read More | ±21.2% | - | – | — | 16.10 M | 1.42 M | 560.13 K | 6.13% | |||
NGENNervGen Pharma Corp. | 1.92 5.85% | +12.3% | 206.44 M | Phase 1 data presentation 2026-09-30 | Phase 1 | 18% NVG-291 is NervGen’s lead neuroreparative peptide targeting spinal cord injury (SCI), specifically chronic cervical SCI. The program has progressed beyond the initial Phase 1 stage, with a Phase 1b/2a proof-of-concept study, identified as NCT05965700, currently underway. This study focuses on cervical motor incomplete SCI and includes both a chronic cohort and a subacute cohort. NervGen has also communicated its alignment with the FDA regarding RESTORE, a planned Phase 3 registrational study aimed at chronic tetraplegia. The chronic cohort of the CONNECT SCI trial enrolled 20 patients and was designed as a randomized, double-blind, placebo-controlled trial assessing 12 weeks of daily subcutaneous administration of NVG-291. Eligibility for the chronic injury cohort is defined as individuals 1-10 years post-injury, and the program is now being positioned for registrational development. Preliminary efficacy results from the chronic cohort are reported as positive, indicating durable improvements in function, independence, and quality of life. However, the available public information lacks comprehensive statistical details, such as p-values, hazard ratios, confidence intervals, or responder analyses. While the data is directionally encouraging, it remains limited in statistical maturity. Safety profiles appear acceptable based on the disclosures reviewed, with no significant safety concerns or discontinuation issues reported in the chronic cohort summaries. The market landscape for chronic cervical SCI is notably sparse, as there are currently no approved disease-modifying therapies. This absence underscores a significant unmet need and supports the characterization of NVG-291 as a first-in-class drug. NervGen describes NVG-291 as a first- and potentially best-in-class neuroreparative peptide, although the current evidence more strongly supports its classification as first-in-class. The market for chronic SCI repair is structurally appealing, yet challenging to quantify accurately due to the lack of existing restorative therapies. A rough estimate suggests a future global market size in the low single-digit billions, contingent upon successful efficacy translation, although this figure remains highly speculative. NervGen has received Fast Track designation for SCI; however, the reviewed public sources do not confirm specific orphan, breakthrough, priority review, or accelerated approval status for chronic cervical SCI. Regulatory designations must be indication-specific, and any claims not explicitly linked to chronic cervical SCI should be treated with caution. The estimated probability of approval (PoA) for NVG-291 stands at 18.0%. This figure is above the average for a Phase 1/2 neuroreparative program, reflecting the positive chronic cohort data generated by the sponsor and the established FDA alignment for a Phase 3 pathway. Nevertheless, the PoA remains below 50% due to the inherent challenges in reproducing SCI efficacy, the small sample size, and the absence of registrational-grade, replicated benefits. NervGen's lack of prior FDA approval history introduces neutral-to-slight execution risk; however, the company has shown progress in capital markets and development within a notably challenging indication. Historical precedents in SCI and central nervous system repair have often failed to translate efficacy, warranting a cautious approach despite early positive signals. Key upcoming catalysts include the initiation of the RESTORE study, further disclosures from Phase 2 extensions, and eventual Phase 3 readouts, although specific timelines have not been disclosed in the public sources reviewed. Read More | ±21.2% | - | – | — | 16.10 M | 1.42 M | 560.13 K | 6.13% | |||
 DYNDyne Therapeutics, Inc. | 16.21 2.33% | -37.7% | 3.03 B | Phase 1/2 data presentation 2026-09-30 | zeleciment basivarsen (z-basivarsen, DYNE-101) myotonic dystrophy type 1 (DM1) BreakthroughFast TrackOrphan | Phase 1/2 | 58% Zeleciment basivarsen (z-basivarsen, formerly DYNE-101) is the lead investigational therapy from Dyne Therapeutics for myotonic dystrophy type 1 (DM1), a rare inherited multisystem disorder characterized by significant unmet medical need and the absence of approved disease-modifying treatments. This drug is an RNA-targeting oligonucleotide conjugate designed to suppress toxic DMPK transcripts, addressing the underlying cause of DM1 rather than merely alleviating symptoms. This innovative mechanism supports its classification as a first-in-class therapy. The development of z-basivarsen has progressed significantly. As of September 9, 2026, Dyne Therapeutics has advanced beyond the Phase 1/2 stage, having initiated the Phase 3 HARMONIA trial in March 2026. This global, randomized, double-blind, placebo-controlled study aims to confirm the efficacy of z-basivarsen in DM1, enrolling 150 participants across 16 sites in eight countries. Additionally, the ongoing Phase 1/2 ACHIEVE study, identified as NCT05481879, is a global, randomized, placebo-controlled, double-blind trial assessing safety, tolerability, and efficacy in adults with DM1. The multiple ascending dose portion of this study has identified a registrational regimen of 6.8 mg/kg administered every eight weeks. Preliminary efficacy data from the ACHIEVE study have been promising, although they remain non-pivotal. Dyne has reported that one-year data from the ACHIEVE study demonstrated clinically meaningful improvements in function and strength at the selected dose. However, the summary information provided does not include specific effect sizes, hazard ratios, or p-values, making the current evidence supportive but not yet definitive for regulatory approval. Safety data appears manageable to date, with no major signals indicating significant safety concerns; nonetheless, the implications of chronic intravenous dosing and long-term tolerability are critical in the context of DM1. Regulatory designations for z-basivarsen are favorable, as the therapy has received FDA Fast Track, Orphan Drug, and Breakthrough Therapy designations for DM1. However, there is currently no evidence suggesting that Priority Review or Accelerated Approval will be applicable for this program. The initiation of the Phase 3 trial indicates that a conventional approval pathway is becoming increasingly plausible, contingent upon the confirmation of functional benefits in the HARMONIA trial. While competition in the DM1 space remains limited, it is highly relevant. Several other programs are exploring RNA-splicing or antisense approaches, but none have achieved approval thus far. A significant challenge for the field lies in demonstrating durable clinical benefits across the heterogeneous spectrum of DM1, particularly given the lack of validated surrogate endpoints. Historical precedents in rare neuromuscular diseases suggest that FDA decisions are heavily influenced by robust functional outcomes, consistency across patient subgroups, and long-term tolerability. For z-basivarsen, the strengths include its novel mechanism, favorable regulatory designations, and progression into Phase 3 trials. Conversely, the primary challenges include the necessity for confirmatory efficacy data and the absence of pivotal results. The estimated probability of approval (PoA) for z-basivarsen stands at 58.0%. This figure reflects a program that has gained momentum in de-risking but still faces the inherent uncertainties typical of late-stage development for a first-in-class therapy targeting a rare disease. Key risks include the need to translate clinical efficacy from Phase 1/2 signals to confirmatory Phase 3 benefits on functional endpoints, the burden of chronic administration, and the safety and tolerability of RNA-targeting therapies. Furthermore, the heterogeneous nature of DM1 means that regulatory success will likely depend on demonstrating durable, clinically meaningful effects rather than solely improvements in biomarkers. Upcoming catalysts include interim or topline efficacy updates from the Phase 3 HARMONIA trial and further long-term follow-up data from the ACHIEVE study, although specific timelines for these updates have not been disclosed. Read More | ±11.4% | -146.78 M | 12 -2% | STABLE | 898.48 M | 43.43 M | 2.29 M | 14.87% | ||
 QUREuniQure N.V. | 24.51 -36.44% | -48.3% | 1.70 B | Phase I/II data readout 2026-09-30 | Phase 1/2 | 67% Ifezuntirgene inilparvovec (AMT-130) is a pioneering gene therapy developed by uniQure, utilizing AAV5 technology for intracranial administration. This innovative therapy aims to reduce levels of mutant huntingtin (mHTT), representing a first-in-class disease-modifying approach for Huntington’s disease. The drug is currently undergoing development through two ongoing Phase 1/2 clinical trials: the U.S. CT-AMT-130-01 trial (NCT04120493) and the European study (NCT05243017). The U.S. trial is characterized as a Phase I/II, randomized, multicenter, multiple-dose, double-blind, imitation-surgery, first-in-human study, while the European trial is a multicenter, first-in-human program targeting early Huntington’s disease, with reported enrollment of 15 patients. The central question driving development is whether this one-time neurosurgical intervention can provide a durable clinical benefit while maintaining an acceptable safety profile. The regulatory landscape for AMT-130 is notably favorable for a neurology asset. Specifically, the therapy has received FDA Fast Track, Orphan Drug, and Breakthrough Therapy designations. Furthermore, uniQure has indicated that the FDA supports using the three-year Phase I/II analysis as the primary basis for a Biologics License Application (BLA) seeking accelerated approval. Although Priority Review has not yet been granted, this designation would typically follow the filing and acceptance of the BLA. The current market for Huntington’s disease treatments is projected to reach approximately $0.89 billion by 2026, a figure that does not fully capture the potential value of a therapy capable of altering the disease course. Efficacy data from the trials suggest that the high-dose cohort achieved its primary endpoint, demonstrating statistically significant slowing of disease progression compared to an external control. However, specific details regarding hazard ratios, confidence intervals, and p-values are not disclosed in the available sources. Safety profiles appear manageable, supporting ongoing development; nonetheless, the program is still subject to risks associated with surgical procedures and long-term gene therapy. A significant competitive advantage for AMT-130 is its differentiation in the market, as there are currently no approved disease-modifying therapies for Huntington’s disease. This positions AMT-130 uniquely, with limited direct competition based on its mechanism of action. The closest competitors include other huntingtin-lowering therapies and broader neurodegeneration programs, many of which are still in earlier stages or have encountered challenges with delivery and translational consistency. Despite the promising regulatory and clinical landscape, there are inherent risks associated with the approval process. The FDA has recently shown a willingness to support accelerated pathways for serious rare diseases when early efficacy signals are compelling. However, the agency remains stringent regarding durability and confirmatory evidence, particularly for irreversible therapies. This nuanced environment results in a positive, yet cautious, probability of approval (PoA) estimate of 67.0%. This figure reflects the strong unmet need in the Huntington’s disease space, favorable FDA designations, and encouraging early efficacy data, while also accounting for the small sample size, reliance on external controls, and the complexities associated with intracranial gene therapy. Read More | ±17.2% | -1.36 M | 14 +14% | HEALTHY | 810.34 M | 9.53 M | 29.81 M | 15.39% | |||
 ACETAdicet Bio, Inc. | 6.83 4.41% | -25.0% | 63.94 M | Phase 1 topline data readout 2026-09 | Phase 1 | 18% Prulacabtagene leucel (prula-cel; formerly ADI-001) is an innovative allogeneic anti-CD20 CAR gamma delta T-cell therapy developed by Adicet Bio for the treatment of autoimmune diseases, specifically systemic lupus erythematosus (SLE) with or without lupus nephritis (LN). This program is particularly noteworthy as it employs a cell therapy platform to target B-cell biology, distinguishing it from traditional monoclonal antibodies and small molecules, thereby positioning it as a credible first-in-class approach for this indication. Currently, the SLE/LN program is in Phase 1 development, with the relevant clinical study registered on ClinicalTrials.gov under NCT06375993. This Phase 1 study is designed to evaluate prula-cel in SLE, while Adicet has indicated that the broader Phase 1 autoimmune program is actively enrolling patients across multiple diseases, including both LN and SLE. It is important to note that this trial is open-label and early-stage, lacking the rigor of randomized, placebo-controlled, or blinded designs, and no mature comparative efficacy data has been publicly reported for this specific program. The publicly disclosed endpoints focus on safety, tolerability, and disease activity measures such as SLEDAI-2K, PGA, and renal function, rather than hard long-term outcomes like overall survival (OS) or progression-free survival (PFS), which are not particularly relevant for this disease. In terms of efficacy, Adicet reported positive preliminary safety and efficacy data in October 2025, indicating rapid and sustained reductions in SLEDAI-2K and PGA, along with improved renal function. However, detailed results akin to objective response rates or statistically powered comparative outcomes were not disclosed in the reviewed materials. Safety data appears encouraging, with management reporting a favorable tolerability profile as of the August 31, 2025 cut-off. Nonetheless, CAR-T therapies in autoimmune diseases face class-wide concerns, including cytokine release syndrome, cytopenias, infection risk, and challenges related to outpatient feasibility. Regulatory-wise, prula-cel has received Fast Track designation from the FDA for relapsed/refractory class III or class IV LN and refractory SLE with extrarenal involvement. However, there is no indication that the program has secured orphan drug, breakthrough therapy, priority review, or accelerated approval designations for SLE/LN. The market opportunity for prula-cel is significant, with third-party estimates projecting a market size of approximately $2.47 billion globally by 2026. The unmet need remains substantial, as many patients continue to experience inadequate disease control with existing therapies, which do not consistently provide durable remission or renal preservation. The competitive landscape includes established therapies such as belimumab and anifrolumab, as well as a burgeoning pipeline of B-cell, BAFF/APRIL, BTK, FcRn, and CAR-T approaches. The estimated probability of approval (PoA) for prula-cel stands at 18.0%. This figure reflects the program's early-stage status, encouraging preliminary data, and the high standards required for safety, durability, and reproducibility in a complex autoimmune indication. Key risks include the lack of randomized pivotal data, uncertainties surrounding execution and regulatory pathways for a living-cell therapy in outpatient settings, and the potential for early improvements to fail in translating into durable clinical benefits. Historical precedents include approved biologics such as belimumab and anifrolumab, which achieved success based on controlled trial evidence in challenging SLE populations, and CAR-T autoimmune programs that have generated significant interest but still require robust long-term validation before FDA approval can be confidently anticipated. Read More | ±52.3% | - | – | STABLE | 118.19 M | 6.61 M | 668.20 K | 3.31% | |||
 ENTAEnanta Pharmaceuticals, Inc. | 12.64 0.20% | -5.0% | 368.15 M | Phase 2b topline data readout 2026-09-30 | Phase 2b | ±24.5% | - | 3 -10% | HEALTHY | 211.49 M | 3.32 M | 322.82 K | 9.37% | ||||
 IVVDInvivyd, Inc. | 0.8501 -10.32% | -2.1% | 250.57 M | BLA Submission 2026-09-30 | BLA | ±48.2% | -341.56 K | 6 +30% | CAUTION | 160.08 M | 14.34 M | 31.29 M | 11.68% | ||||
S SVASinovac Biotech, Ltd | 6.47 -0.31% | — | 464.94 M | NDA Submission Q3 2026 | NDA | – | - | – | — | - | - | 8.23 K | 0.45% | ||||
 EVMNEvommune, Inc. | 8.35 -0.48% | -41.3% | 303.04 M | Phase 2b topline data readout Q3 2026 | Phase 2b | ±14.4% | 146.26 K | 7 -24% | HEALTHY | 288.01 M | 6.77 M | 807.60 K | 13.76% | ||||
 UPBUpstream Bio, Inc. | 5.19 -2.08% | -24.2% | 284.26 M | Phase 2 data readout 2026-09-30 | Phase 2 | ±18.8% | -27.60 K | 5 -11% | STABLE | 261.31 M | 11.87 M | 784.21 K | 12.04% |
• 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.