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Historical FDA Catalyst Database & Approval Archive

Analyze historical FDA approval trends with a searchable archive of past PDUFA decisions, Complete Response Letters (CRLs), and key regulatory outcomes across biotech and pharma.
Showing 6 Drugs Out Of 1424. Click On The Tickers For More Details
Ticker Name Price 30-Day Trend Market Capital Event Type Drug Name Run Up/Down Catalyst Date Poa % Poa Summary Stage Treatment Hedge Funds Description Source
SILO
Silo Pharma, Inc.
6.12 5.34 %
-3.5%
6.4M
IND Submission
-25.05%
8%

SPC-15, developed by Silo Pharma (NASDAQ: SILO), is a novel intranasal serotonin 5-HT4 receptor agonist aimed at preventing post-traumatic stress disorder (PTSD). Currently in the IND-enabling preclinical phase, the company plans to submit an Investigational New Drug (IND) application by late 2025. To date, SPC-15 has completed animal studies, showing no local or systemic toxicity and favorable pharmacokinetics, comparable to oral formulations, which is a prerequisite for clinical testing. However, there is currently no human data available, nor any objective response rates or statistical efficacy outcomes, leaving its efficacy and long-term safety in humans entirely unproven. The program is being prepared for the FDA's 505(b)(2) pathway, potentially allowing for an expedited review process based on existing safety or efficacy data from reference drugs. SPC-15’s mechanism of action is unique in the context of PTSD, as it differs from the two currently approved PTSD medications, which are both SSRIs, and from various historical candidates that have failed in this area. CNS small molecules, particularly those aimed at PTSD, have historically shown low Phase 1-to-approval probabilities, with average approval chances estimated at 5–8%, reflecting high attrition rates due to efficacy and safety concerns. Regulatory authorities have not approved a new therapy for PTSD in over two decades, indicating significant challenges in this indication. Currently, there are no Fast Track, Orphan Drug, or Breakthrough Therapy designations for SPC-15, and no PDUFA date has been set, as the drug has not yet entered clinical trials. Ongoing device studies are focused on the proprietary microchip-based nasal spray system, but no human pharmacodynamic or comparative studies against standard care have been reported. Silo Pharma retains global commercialization rights and is collaborating with Columbia University; however, the company has not previously brought a drug through FDA or EMA approval, introducing additional execution risk. Considering the early development stage, lack of human data, specific challenges in CNS and PTSD drug development, and absence of regulatory acceleration, the estimated probability of approval for SPC-15 remains at 5–8%, in line with historical trends in CNS small molecule development.

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IND
20%

Post-traumatic stress disorder

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N/A
STTK
Shattuck Labs, Inc.
4.95 4.43 %
-23.1%
467.8M
phase 1 data readout
28.19%
47%

SL-325 is a first-in-class Death Receptor 3 (DR3) blocking antibody developed by Shattuck Labs for the treatment of Crohn's disease. This innovative therapeutic candidate aims to achieve a complete and durable blockade of the DR3/TL1A signaling pathway, which has shown compelling monotherapy efficacy in inflammatory bowel disease (IBD) based on existing clinical literature. As of March 2026, SL-325 is in Phase 1 clinical trials, with data anticipated in the second quarter of 2026, and the company plans to initiate Phase 2 trials in Crohn's disease patients in the third quarter of 2026. The market analysis indicates a significant unmet medical need in Crohn's disease, affecting hundreds of thousands of patients globally. Despite the availability of established therapies such as TNF inhibitors, integrin antagonists, and JAK inhibitors, many patients continue to experience inadequate disease control, loss of response, or intolerable side effects. Although specific global market size figures for Crohn's disease are not provided, the strategic focus on SL-325 and its planned Phase 2 development highlight the perceived necessity for novel therapeutic approaches targeting the DR3/TL1A pathway. SL-325 is classified as a first-in-class drug, representing the first DR3 blocking antibody to enter human clinical trials. Preclinical studies have demonstrated high-affinity binding and superior activity compared to TL1A antibodies, providing a rationale for targeting the TNF receptor (DR3) rather than its ligand (TL1A). This mechanistic distinction positions SL-325 as a potentially differentiated approach within the competitive IBD therapeutic landscape. The ongoing Phase 1 trial is a randomized, double-blind, placebo-controlled study involving healthy volunteers, designed to evaluate safety, tolerability, immunogenicity, and pharmacokinetics. The trial is nearing completion, with results expected in the second quarter of 2026. Preclinical studies in non-human primates have shown no evidence of toxicity or residual DR3 agonism, and the receptor occupancy and pharmacokinetic profile suggest that extended dosing intervals may be feasible in humans. These favorable preclinical findings support the progression to Phase 2 trials. Currently, no clinical efficacy data are available, as the Phase 1 trial focuses on safety and pharmacokinetics in healthy volunteers rather than efficacy in patients. However, the robust preclinical safety profile, which includes GLP toxicology studies in cynomolgus macaques showing no toxicity signals or residual agonism at any dose level, enhances confidence in the drug's potential. The possibility of extended dosing intervals could also provide clinical advantages regarding patient convenience and compliance. As of now, SL-325 has not received any regulatory designations such as Fast Track, Breakthrough Therapy, Orphan Drug, Priority Review, or Accelerated Approval for Crohn's disease. This absence of special designations suggests that the FDA has not prioritized the program, which may indicate either early-stage evaluation or a standard regulatory pathway. The competitive landscape for Crohn's disease is highly saturated, with multiple approved therapies including TNF inhibitors, integrin antagonists, IL-12/IL-23 inhibitors, and JAK inhibitors. While SL-325's first-in-class status and novel mechanism offer potential differentiation, demonstrating clinical superiority over established therapies will be crucial for market penetration. The estimated probability of approval (PoA) for SL-325 is 42-52%. This assessment reflects a balanced view of significant opportunities and material risks. Positive factors include the first-in-class mechanism targeting a validated pathway, favorable preclinical safety data, and adequate funding to support clinical development. However, the program remains in early-stage development, with no human efficacy data and no regulatory designations to expedite review. The competitive IBD market and the binary nature of Phase 2 success present substantial risks. Approval will depend critically on Phase 1 data demonstrating acceptable safety and pharmacokinetics, followed by Phase 2 efficacy results that differentiate SL-325 from existing therapies. Key risks associated with SL-325 include potential safety or pharmacokinetic concerns arising from the Phase 1 trial, the possibility of Phase 2 efficacy failure, competitive displacement by other novel IBD therapies, regulatory pathway uncertainties, and manufacturing challenges. Significant upcoming catalysts include the Phase 1 data release in Q2 2026 and the Phase 2 trial initiation in Q3 2026, both of which will play a pivotal role in shaping the risk-benefit profile and investment thesis for Shattuck Labs.

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Phase 1
20%

Crohn’s disease

3
TCRX
TScan Therapeutics, Inc.
0.92 2.23 %
-24.8%
69.3M
phase 1 data readout
3.89%
40%

TSC-101, developed by TScan Therapeutics (TCRX), is an innovative allogeneic, donor-derived T-cell receptor (TCR)-T therapy designed to target minor histocompatibility antigens (minor H antigens) that are present on recipient hematopoietic cells but absent on donor cells. This unique mechanism aims to selectively eliminate residual recipient disease following allogeneic hematopoietic cell transplantation (allo-HCT), thereby preventing relapse in hematologic malignancies without the need for broad immunosuppression. As a first-in-class approach, TSC-101 stands out from existing therapies such as bispecific antibodies, antibody-drug conjugates (ADCs), and checkpoint inhibitors by utilizing precise TCR targeting in the post-HCT setting, where there are currently no direct competitors employing this mechanism of action. The global market for hematologic malignancies is substantial, exceeding $15 billion, driven by the high incidence of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). There is a significant unmet need in this space, as relapse rates post-allo-HCT can range from 30% to 50%, despite the use of conditioning regimens. TSC-101 aims to address this unmet need by promoting long-term T-cell persistence and chimerism, which may allow for an expanded patient population through follow-on candidates such as TSC-102. Currently, TSC-101 is in Phase 1 development, being evaluated in the ALLOHA trial (NCT number not specified). This trial focuses on A*02:01-positive patients with hematologic malignancies undergoing allo-HCT. The multi-cohort, open-label design includes an internal control arm, with Cohort C (n>10) having completed its evaluation using commercial-ready manufacturing. The primary endpoints of the trial are safety, chimerism, and relapse-free survival (RFS), while secondary endpoints include persistence and efficacy signals. Preliminary Phase 1 data presented at the December 2025 ASH meeting indicated favorable safety profiles, durable persistence exceeding two years, a dose-response correlation, and a notable RFS benefit—82% relapse-free survival in the treatment group compared to 64% in the control group. Importantly, no severe adverse events or graft-versus-host disease signals were reported, which supports the FDA's alignment on a pivotal trial that will mirror the ALLOHA trial, with RFS as the primary endpoint for AML/MDS, set to launch in Q2 2026. Despite the promising data, TSC-101 has not received any regulatory designations for hematologic malignancies, such as Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval. The competitive landscape includes established therapies like venetoclax/azacitidine in AML, but there is a notable absence of options specifically targeting post-HCT relapse prevention. While there are other TCR-T therapies in development, TSC-101's donor-derived, off-the-shelf format provides a competitive advantage. The estimated probability of approval (PoA) for TSC-101 is 35-45%. This reflects the strong momentum observed in Phase 1, with promising efficacy and safety data, as well as alignment with the FDA for pivotal trial execution. However, the PoA is tempered by risks associated with pivotal execution in a novel modality, given the small sample size of 31 total patients and the absence of randomization or blinding to date. Historical data suggests that approximately 50% of Phase 2/3 trials for hematologic biologics with similar profiles succeed, although this is discounted due to uncertainties surrounding manufacturing and expansion capabilities. The sponsor has a clean track record with no prior approvals or rejections and has received FDA IND clearances for TSC-102, which extends the runway to H2 2027. Key risks include potential data underperformance, delays, or increased competition. Upcoming catalysts, including the Q2 2026 readout for Cohort C and the pivotal trial launch, may mitigate near-term risks. If TSC-101 maintains its RFS benefits, TScan Therapeutics could position itself for significant market success, targeting peak sales exceeding $1 billion in the relapse prevention market.

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Phase 1
20%

Hematologic malignancies

2
QURE
uniQure N.V.
46.29 -3.88 %
+94.7%
1.5B
Phase 1/IIa data readout
-
18.5%

AMT-260, developed by uniQure N.V. (QURE), represents a groundbreaking advancement in the treatment of refractory mesial temporal lobe epilepsy (MTLE), a severe form of focal epilepsy that affects the hippocampus and is resistant to conventional antiseizure medications. This innovative therapy utilizes an AAV9-based gene therapy approach, administered through a one-time intraparenchymal injection via MRI-guided convection-enhanced delivery (CED). The therapy is designed to express two engineered microRNAs (miGRIK2) under a synapsin-1 promoter, effectively targeting and reducing aberrant GRIK2 gene expression. The GRIK2 gene encodes the GluK2 subunit of kainate receptors, which contribute to hyperexcitability in MTLE. Preclinical studies have demonstrated a remarkable potential, with seizure reductions of up to 75% observed following precise hippocampal transduction. The global market for refractory MTLE is estimated to be $1.2 billion, representing a subset of the larger $8-10 billion epilepsy market. This market is primarily driven by approximately 3 million drug-resistant patients worldwide who are in urgent need of alternatives to surgical interventions. The unmet need in this space is significant; up to 40% of MTLE patients do not achieve seizure control despite trying four or more antiseizure medications. Current surgical options, such as laser ablation or temporal lobectomy, offer only 50-70% seizure freedom and carry the risk of cognitive and mnemonic deficits. AMT-260 is positioned as a first-in-class therapy, as no existing approved treatments utilize AAV-miRNA gene silencing for GRIK2 knockdown, distinguishing it from traditional small-molecule antiseizure drugs or neuromodulation devices like the RNS System. Currently, AMT-260 is undergoing Phase 1/2a clinical trials, specifically the GenTLE trial (NCT06063850), which is a multicenter, open-label, non-randomized study enrolling approximately 12 adults aged 18-75 with confirmed unilateral refractory MTLE. These patients experience at least two focal impaired awareness or tonic-clonic seizures every 30 days despite being on a stable regimen of up to four antiseizure medications. The primary endpoints of the trial focus on safety and tolerability, while secondary endpoints assess the reduction in seizure frequency. As of May 2025, the first low-dose patient, dosed in late 2024 or early 2025, exhibited promising results, with seizures decreasing from seven per month prior to treatment to just two over five months, including a period of 60 days without seizures. Importantly, no serious adverse events have been reported, indicating the tolerability of this novel delivery method. Enrollment for the first cohort (n=6 low-dose) commenced in September 2025, with a second higher-dose cohort planned. The trial is expected to conclude in 2031 across 18 U.S. sites, including institutions such as Rutgers RWJUH and OSU. Currently, AMT-260 has not received any specific regulatory designations for MTLE, such as Fast Track, Orphan Drug, or Breakthrough Therapy status, although the U.S. Investigational New Drug (IND) application is active. In terms of competitive landscape, there are no direct rivals targeting MTLE or GRIK2, with existing pipeline candidates primarily focused on other developmental and epileptic encephalopathies. Approved treatments remain symptomatic or ablative rather than disease-modifying like AMT-260. The estimated probability of approval (PoA) for AMT-260 stands at 18.5%. This figure reflects a baseline of approximately 10% for Phase 1 CNS gene therapies, adjusted upward due to the promising efficacy signal observed in a single patient, the favorable safety profile, the first-in-class nature of the therapy, and the significant unmet medical need. However, this PoA is tempered by the limitations of single-patient data, the small trial size of n=12, the extended timeline to 2031, and the inherent risks associated with AAV gene therapies, which typically experience a 20-30% attrition rate in Phase 1-3 trials. The success of AMT-260 will depend on the expansion of the cohort confirming a responder rate of at least 50%. Key risks include potential efficacy fade, challenges in delivery precision, and immune responses. Upcoming catalysts, such as additional data from the first dose cohort, could significantly impact share performance. While QURE has a history of challenges with AMT-101, AMT-260 has the potential to become a cornerstone of its pipeline if validated.

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Phase 1
20%

refractory mesial temporal lob

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10
SPRO
Spero Therapeutics, Inc.
2.28 8.06 %
-11.2%
159.8M
PDUFA Date
-
92.5%

Tebipenem HBr (tebipenem pivoxil hydrobromide, formerly SPR994), developed by Spero Therapeutics (SPRO), is an innovative oral carbapenem antibiotic specifically targeting complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. As the first oral agent in the carbapenem class—traditionally restricted to intravenous (IV) administration due to bioavailability challenges—tebipenem HBr fills a significant gap in treatment options by facilitating outpatient or step-down therapy. This advancement has the potential to reduce hospitalization duration and associated healthcare costs. The drug's mechanism involves rapid conversion in plasma to active tebipenem, demonstrating potent in vitro activity against multidrug-resistant uropathogens, including fluoroquinolone-resistant and extended-spectrum β-lactamase (ESBL)-producing Enterobacterales. The global market for cUTI treatments is projected to reach $2.5 billion by 2025, driven by a high incidence of cases, with millions reported annually, and increasing resistance rates that exceed 20-30% for standard oral therapies such as fluoroquinolones and trimethoprim-sulfamethoxazole. A significant unmet need exists, as resistant infections often require IV carbapenems (e.g., ertapenem, imipenem) in hospital settings, with few effective oral alternatives available. Tebipenem HBr is unequivocally classified as first-in-class, being the inaugural oral carbapenem that offers enhanced convenience over IV standards without compromising efficacy. The development of tebipenem HBr has progressed to the PDUFA stage following the completion of two pivotal Phase 3 trials. The ADAPT-PO trial (NCT03788967) randomized 868 hospitalized adults with cUTI (50.8%) or acute pyelonephritis (49.2%) in a 1:1 ratio to receive either oral tebipenem HBr (600 mg every 8 hours) or IV ertapenem (1 g every 24 hours) for a duration of 7-10 days (up to 14 days for bacteremia). The trial successfully met its primary endpoint of overall response (clinical cure plus microbiologic eradication) at test-of-cure (TOC, Day 19±2), reporting results of 58.8% for tebipenem HBr versus 61.6% for ertapenem (difference -3.3%; 95% CI -9.7 to 3.2, within the -12.5% noninferiority margin). Clinical cure rates were 93.1% for tebipenem HBr compared to 93.6% for ertapenem, with microbiologic responses at 59.5% versus 63.5%, respectively. The subsequent PIVOT-PO trial (NCT06059846), which enrolled 1,690 patients, compared tebipenem HBr to IV imipenem-cilastatin and was stopped early for efficacy in May 2025. This trial confirmed noninferiority with overall success rates of 58.5% for tebipenem HBr versus 60.2% for imipenem-cilastatin, including in ESBL+ subsets, and maintained high clinical cure rates exceeding 90%. Safety profiles were favorable across both trials, with treatment-emergent adverse events reported in approximately 25-26% of patients, primarily mild diarrhea, nausea, and headache. Drug-related adverse events were noted in 6-9% of patients, with discontinuations being less than 1%. No new safety signals emerged, aligning with the safety profiles of IV comparators. Regulatory momentum for tebipenem HBr is strong, with Fast Track and Priority Review designations specifically for cUTI and pyelonephritis. However, it does not hold Orphan or Breakthrough status. Spero's track record for this asset is clean, further supported by a partnership with GSK, which acquired rights post-PIVOT-PO. The competitive landscape includes IV carbapenems and oral agents such as nitrofurantoin and fosfomycin, but none match tebipenem's broad-spectrum oral profile against resistant Gram-negative pathogens. Historical precedents, such as meropenem-vaborbactam and plazomicin, have demonstrated that robust Phase 3 data can lead to successful approvals despite resistance challenges. The estimated probability of approval (PoA) for tebipenem HBr stands at 92.5%, reflecting the positive outcomes from dual Phase 3 noninferiority trials, a clean safety profile, Priority Review status, and its first-in-class designation in a high-need therapeutic area. While risks remain, including potential inspectional hurdles or narrow labeling, the robustness of the data mitigates these concerns. For investors in Spero Therapeutics, approval could unlock peak sales exceeding $500 million, significantly transforming the company through the adoption of this oral therapy amid increasing stewardship pressures.

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PDUFA
100%

complicated urinary tract infe

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N/A
ENTX
Entera Bio Ltd.
1.21 0.83 %
-10.9%
61.0M
Pre-clinical data readout
4.24%
7.5%

Entera Bio’s EB612 represents a novel approach to treating hypoparathyroidism through its oral PTH(1-34) peptide replacement therapy, leveraging the company’s proprietary N-Tab technology platform. This program is positioned as the first oral daily tablet replacement therapy for a condition that is primarily managed with calcium and active vitamin D supplementation. Currently, the only approved PTH replacement therapy is injectable, which underscores EB612's potential as a first-in-class treatment. However, the development of oral peptide hormones presents significant technical challenges, and the clinical dataset for EB612 remains in the early stages. The market for hypoparathyroidism is estimated to be between $1.0 billion and $2.0 billion globally, although precise public consensus figures are not well established. There is a clear unmet need in this space, as chronic hypoparathyroidism lacks a convenient physiologic replacement option. Current therapies mainly consist of calcium and calcitriol supplementation, while the only approved PTH replacement requires daily injections. This gap highlights the demand for a safer, effective, non-injectable PTH replacement therapy. EB612 has not received any publicly documented FDA designations for hypoparathyroidism, which is a critical factor in its regulatory outlook. The absence of Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval designations indicates a weak regulatory position for this indication. Consequently, the estimated probability of approval (PoA) stands at 7.5%, reflecting the challenges that lie ahead. In terms of development status, the most documented human study is NCT03516773, which evaluated the pharmacokinetics and pharmacodynamics of oral EB612 in adults with hypoparathyroidism. This study employed a randomized, active-comparator, partial crossover design, comparing various dosing regimens of EB612 with NATPARA/NATPAR. However, the public record does not include mature efficacy outcomes relevant to this endocrine indication. A subsequent Phase 1 study (NCT05965167) involving 15 healthy young male subjects demonstrated significant systemic exposure following BID oral dosing, with favorable changes in calcium, phosphate, and 1,25(OH)2-vitamin D levels, and no reports of hypercalcemia or serious adverse events. The competitive landscape for hypoparathyroidism is becoming increasingly crowded, with existing injectable PTH therapies and investigational weekly injectables posing significant competition. Entera must demonstrate clear convenience and clinical benefits to justify EB612's approval and eventual market adoption. The main approval question revolves around whether an oral peptide can provide consistent exposure, durable calcium control, and an acceptable safety profile in a pivotal population. Key risks include the very early clinical maturity of EB612, as it remains pre-clinical overall despite limited Phase 1 human data. Additionally, oral peptide delivery has historically faced bioavailability and variability challenges, and the current evidence base is limited to small, early studies. The lack of pivotal efficacy data further complicates the approval process. Upcoming catalysts include further preclinical updates on the long-acting PTH analog program, initiation of the next clinical study or Phase 2 development in hypoparathyroidism, and additional clinical data disclosures for EB612, although specific timelines for these events have not been disclosed. In summary, while EB612 holds promise as a first-in-class oral therapy for hypoparathyroidism, the current regulatory landscape, competitive pressures, and early-stage clinical data present substantial challenges. The estimated PoA of 7.5% reflects these complexities, emphasizing the need for robust clinical evidence to support its potential in the market.

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Pre-clinical
10%

hypoparathyroidism

1
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• FAQs

Frequently asked questions about historical FDA data

The approval archive above lists past FDA approvals and Complete Response Letters by date, so you can pull up the decisions from any given week or month and see the company, drug, and indication for each. It captures both clearances and rejections, which matters because a withheld approval (a CRL) is often as informative as a positive outcome. To browse the dataset, sort or filter the archive by the period you care about. For decisions that have not happened yet, switch to the upcoming calendar rather than this historical record.

It is a searchable record of past FDA decision dates and the outcomes attached to them: which drugs were approved, which received a Complete Response Letter, and when each decision landed. Unlike a forward calendar of pending events, the archive above lets you study completed catalysts and trace how specific approvals played out over time. You can review outcomes across biotech and pharma in one dated view, then jump to the live calendar for decisions still ahead.

A Complete Response Letter means the FDA declined to approve an application in its then-current form and asked the company to fix specific deficiencies, which can span manufacturing, labeling, safety, or efficacy. Browsing past CRLs in the archive above shows how a given type of problem tended to be resolved on resubmission and roughly how long the second review cycle ran. Because a CRL starts a new review clock and a new decision deadline, the record often shows a later approval for the same drug once the issues were addressed. This is general information, not investment advice.

Looking back at completed decisions in the archive above helps you see how frequently drugs in a given phase, disease area, or review type were approved, and how the underlying stocks tended to react. That retrospective context is the foundation for gauging the probability and risk of similar events still to come. Pair the archive with the live calendar so you can move from studying what already happened to tracking what is coming next. This is general information, not investment advice.

The review deadline (the PDUFA date) is the FDA's target to act on an application, while the approval date is the day the agency actually clears the drug, which can fall on, before, or after that target. In the archive above both can appear, and the gap between them shows whether a decision came early, on time, or after an extension to assess new information. Not every listed deadline ends in an approval: some past entries resolve as a Complete Response Letter rather than a clearance.

A New Drug Application (NDA) is the submission used to clear 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 decision timelines and both resolve as either an approval or a Complete Response Letter, so both appear throughout the approval archive above. The distinction is worth noting when comparing historical approvals, because biologics follow a separate regulatory pathway with different exclusivity rules.

The archive above is compiled from primary disclosures: FDA approval announcements, company press releases, and SEC filings, then consolidated into one dated view of decisions and outcomes. Past entries are retained after a decision is issued, so the timeline stays auditable and you can reconstruct what was known and when. For decisions still pending, the upcoming calendar is the place to look rather than this archive.