Regulatory
54FDA approvals and PDUFA decision dates, newest first.
- PDUFA Date
Otsuka's centanafadine faces July 24 FDA decision for adult ADHD
The priority-review verdict on Otsuka's serotonin-norepinephrine-dopamine reuptake inhibitor rests on two pivotal trials that already met their primary endpoint against placebo.
NCT03605680 - PDUFA Date
Otsuka's centanafadine faces July 24 FDA verdict after positive ADHD anxiety data
The FDA reviews centanafadine for ADHD under Priority Review as Otsuka's separate Phase 3b trial in comorbid anxiety just cleared its endpoint, adding supportive data ahead of the decision.
NCT06973577 - PDUFA Date
Regeneron's garetosmab nears FDA verdict on 94% HO-lesion cut in FOP
The FDA is due to rule on garetosmab by the end of August 2026, weighing a Priority Review BLA built on OPTIMA's Phase 3 lesion-reduction data against a trial whose primary endpoint was safety, not lesion count.
NCT05394116 - PDUFA Date
GSK's bepirovirsen heads to FDA decision on positive Phase 3 cure data
The October 26 PDUFA date tests whether two positive Phase 3 trials translate into the first approved functional-cure therapy for chronic hepatitis B.
NCT05630807 - PDUFA Date
Ultragenyx's DTX401 gene therapy faces FDA priority review verdict August 23
The FDA's Priority Review decision on DTX401 would deliver the first therapy addressing GSDIa's underlying enzyme deficiency, resting on a 49-patient Phase 3 that already met its primary endpoint.
NCT05139316 - Regulatory Approval
Ocugen's OCU400 heads toward a 2026 EMA filing decision in retinitis pigmentosa
Ocugen says its gene therapy remains on track for EMA marketing authorization this year, even as the Phase 3 trial backing the filing pushed its completion date out to 2027.
NCT06388200 - FULL APPROVAL
FDA approves Celcuity's REVTORPYK, first pan-PI3K/mTOR drug, in HR+/HER2- breast cancer
The approval rests on VIKTORIA-1 data showing gedatolisib cut progression risk 76% with palbociclib and 67% without it, versus fulvestrant alone.
NCT05501886 - PDUFA Date
Celcuity's gedatolisib faces July 17 FDA decision on 16.6-month PFS data
The PDUFA date tests whether a 14.7-month progression-free survival gain over fulvestrant alone converts to approval under Priority Review and Real-Time Oncology Review.
NCT05501886 - PDUFA Date
Viatris awaits July 30 FDA decision on low-dose estrogen contraceptive patch
The 505(b)(2) filing rests on a completed Phase 3 trial that already reported a 4.14 Pearl Index, leaving the label and any FDA follow-up requests as the open questions.
NCT05139121 - PDUFA Date
Moderna's mRNA-1010 flu shot heads to FDA on a 26.6% efficacy edge over standard vaccines
The August 5 PDUFA date tests whether a Phase 3 win against licensed flu vaccines in adults 50 and older, published in NEJM, converts into the first mRNA seasonal flu approval.
NCT06602024 - FULL APPROVAL
FDA approves once-weekly subcutaneous LEQEMBI IQLIK for early Alzheimer's
The approval lets patients start lecanemab with a 15-second weekly injection instead of an IV infusion, backed by exposure data showing the shot matches IV dosing.
NCT03887455 - PDUFA Date
Elevar's lirafugratinib faces Sept. 27 FDA decision on 46.5% ORR in bile duct cancer
Priority review for the FGFR2 inhibitor rests on a single-arm response rate in FGFR2 fusion-positive cholangiocarcinoma, with no other FGFR2-targeted drug in Phase 3 for this population.
NCT04526106 - PDUFA Date
Nuvalent's zidesamtinib nears Sept. 18 FDA decision on breakthrough-tagged ROS1 NSCLC drug
The pending decision covers TKI pre-treated ROS1-positive NSCLC, a setting where zidesamtinib holds breakthrough and orphan designations and the feeding trial itself remains open and recruiting.
NCT05118789 - PDUFA Date
Mirum's zilurgisertib nears Sept. 26 FDA verdict as first ALK2 drug for FOP
The FDA's priority review of Incyte's ALK2 inhibitor, licensed to Mirum, would deliver the first approved drug for the connective-tissue disease, with no direct comparator yet through review.
NCT05090891 - PDUFA Date
FDA priority review sets Aug. 27 decision on Gilead's BIC/LEN switch pill
The once-daily combination must show it holds virologic suppression as well as complex regimens it aims to replace, after Phase 3 data already backed the filing.
NCT05502341 - Regulatory Approval
Etripamil awaits NMPA verdict in China after already winning FDA nod
Corxel's nasal-spray PSVT drug seeks approval in China by the third quarter of 2026, a market with 3 to 6 million patients, building on its December 2025 FDA clearance.
NCT03464019 - PDUFA Date
Praxis faces Sept. 27 FDA decision on relutrigine while its own trial still enrolls
The PDUFA date for relutrigine in SCN2A/SCN8A epilepsy lands two months before the Phase 3 EMERALD trial's own primary completion date, leaving the confirmatory readout to trail the regulatory decision.
NCT07010471 - PDUFA Date
BMS's Camzyos hits Week 28 goal in teens, sets up Sept. 30 FDA call
SCOUT-HCM cut Valsalva LVOT gradient by 48.0 mm Hg versus placebo, and the FDA will decide by September 30 whether that extends Camzyos to adolescents with obstructive HCM.
NCT06253221 - PDUFA Date
Inhibrx's DR5 antibody ozekibart heads to FDA review after halving progression risk
The ChonDRAgon trial met its primary endpoint with a 52% reduction in progression or death versus placebo, setting up an April 2027 FDA decision in a cancer with no approved systemic therapy.
NCT04950075 - PDUFA Date
Apnimed's AD109 heads to FDA review after 55.6% AHI drop in sleep apnea trial
The SynAIRgy trial's primary endpoint is already public: AD109 cut apnea events by more than half versus placebo, setting the stage for a Q1 2027 FDA decision on the first oral drug for obstructive sleep apnea.
NCT05813275 - Regulatory Approval
Nxera's daridorexant hits sTST goal in South Korea Phase 3, eyes 2027 nod
The Phase 3 trial met all primary and secondary endpoints on subjective sleep time, positioning an MAA filing and a Q1 2027 approval target for an already-approved insomnia drug.
NCT07028697 - Regulatory Approval
Everest Medicines takes China rights to LENZ's approved presbyopia drop VIZZ
NMPA approval of aceclidine drop LNZ100 in China is anticipated in Q1 2027, resting on the same Phase 3 program that already won U.S. approval, not a new efficacy bar.
NCT06045299 - Regulatory Approval
Savara's inhaled GM-CSF nears an EU verdict backed by a positive Phase 3 DLCO result
MOLBREEVI's CHMP decision is expected in Q1 2027, arriving after IMPALA-2 already reported a lung-function benefit over placebo, with FDA and MHRA reviews running in parallel.
NCT04544293 - PDUFA Date
FDA to decide on zipalertinib for EGFR exon 20 NSCLC by Feb. 27, 2027
The NDA rests on a 35% response rate in 176 pretreated patients from the REZILIENT1 trial, in a field where no exon-20-targeted therapy has yet cleared amivantamab-based regimens as the benchmark to beat.
NCT04036682 - PDUFA Date
Gilead's weekly oral lenacapavir PrEP pill faces FDA decision Feb. 2, 2027
The sNDA leans on injectable Yeztugo's already-established PURPOSE 1 and PURPOSE 2 efficacy data, so the decision turns on whether a daily pill matches that bar, not on new trial results.
NCT04925752 - Regulatory Approval
Rhythm's setmelanotide awaits Japan verdict after US and EU nods in hypothalamic obesity
Japan's PMDA is reviewing setmelanotide for acquired hypothalamic obesity after the same pivotal trial cleared the FDA and European Commission this year, with a decision expected in the second half of 2026.
NCT05774756 - Regulatory Approval
MaaT013 awaits EMA verdict after 62% GI response rate in ARES trial
The EMA is weighing approval of MaaT Pharma's fecal microbiome therapy for gut GvHD after it failed on no arm to compare against, in patients other treatments had already failed.
NCT04769895 - Regulatory Approval
Ionis targets a 2026 launch for zilganersen, its first neurology drug filing
The Phase 3 trial behind the Alexander disease therapy finished enrollment at 54 patients after a target cut from 73, with Ionis still guiding to an NDA filing and launch this year.
NCT04849741 - PDUFA Date
PolyPid's D-PLEX100 heads to FDA review with a PDUFA date near Q1 2027
The NDA rests on a completed 800-patient trial, Breakthrough Therapy and Fast Track status, and no approved drug yet prevents surgical site infection this way.
NCT04411199 - Regulatory Approval
Adagio's vCLAS posts 59% VT-free rate at 6 months ahead of PMA decision
FULCRUM-VT's single-arm pivotal data show 84% freedom from ICD shock and a 2.4% adverse-event rate, setting the bar for the FDA's expected 2026 marketing decision.
NCT05675865 - Regulatory Approval
Edwards awaits FDA call on PASCAL for tricuspid regurgitation as pivotal trial keeps enrolling
Edwards expects a Q4 2026 FDA decision on PASCAL for tricuspid regurgitation, but the pivotal CLASP II TR trial's own completion date runs to December 2027, after a 46% enrollment target increase.
NCT04097145 - Regulatory Approval
IceCure asks Health Canada to widen ProSense cryoablation to older women
A Health Canada decision expected in H2 2026 would extend the FDA-cleared cryoablation device to a broader population, three years after FDA denied the same claim on the same trial data.
NCT02200705 - PDUFA Date
Vertex's povetacicept BLA in IgA nephropathy carries a positive Week 36 result into FDA review
The RAINIER trial's interim data already showed a 49.8% placebo-adjusted UPCR reduction, so the November 30, 2026 decision now tests confirmatory durability, not first proof of concept.
NCT06564142 - Regulatory Approval
Moderna's mRNA-1010 flu shot clears FDA and Health Canada review acceptance
Phase 3 data show a 26.6% relative efficacy edge over a licensed flu vaccine, and regulators in the US, Canada, EU and Australia have taken the filing under review ahead of Moderna's first potential flu approval.
NCT06602024 - PDUFA Date
Viatris awaits Dec. 27 FDA verdict on non-opioid pain drug meloxicam-107A-02
Two positive Phase 3 trials backed the NDA for fast-acting meloxicam; the FDA's review now turns on whether that data supports a non-opioid first-line option for acute pain.
NCT06215820 - PDUFA Date
FDA priority review sets Sept. 19 decision on AQNEURSA for A-T
IntraBio's supplemental filing seeks the first approved therapy for ataxia-telangiectasia, built on a 17-patient trial that later terminated after results posted.
NCT03759678 - PDUFA Date
IntraBio's AQNEURSA nears FDA verdict as first drug for A-T
The Phase 3 trial already showed a 1.88-point SARA benefit over placebo with p<0.001, and the FDA's September 19 priority review decides if that becomes the first approved A-T therapy.
NCT06673056 - PDUFA Date
FDA priority review sets up Q3 verdict on rusfertide for polycythemia vera
Takeda and Protagonist's hepcidin mimetic faces an FDA decision built on Phase 3 VERIFY and Phase 2 REVIVE data, in a disease with no approved therapy that directly targets the mechanism driving red-cell overproduction.
NCT04057040 - PDUFA Date
FDA priority review of Jazz's Ziihera in first-line gastric cancer nears Aug. 25 decision
The sBLA rests on HERIZON-GEA-01, the only Phase 3 trial testing a HER2-directed regimen in this first-line population, with Breakthrough Therapy designation already in hand.
NCT05152147 - PDUFA Date
FDA reviews WINREVAIR label expansion off HYPERION's worsening-event data
Merck's sBLA rests on HYPERION's time-to-clinical-worsening result in newly diagnosed PAH, due September 21, 2026, even as the trial itself ended in Terminated status.
NCT04811092 - PDUFA Date
Scholar Rock's apitegromab faces Sept. 30 FDA decision on SMA muscle drug
The BLA rests on a Phase 3 trial the company says met its primary endpoint, with the September 30 PDUFA date now turning on manufacturing inspections rather than the clinical data.
NCT05156320 - PDUFA Date
PharmaEssentia's BESREMi faces Aug. 30 FDA decision in essential thrombocythemia
The sBLA seeks the first U.S. label expansion of an already-approved interferon into a second blood-cancer indication, with Taiwan's approval in hand and no BESREMi-specific data disclosed yet.
NCT04285086 - PDUFA Date
Telix's PET imaging agent TLX101-Px faces Sept. 11 FDA decision for glioma
The NDA for TLX101-Px, an F-18 PET tracer to distinguish tumor regrowth from treatment effect in glioma, carries Fast Track and Orphan Drug status ahead of its September 11 PDUFA date.
NCT06743100 - PDUFA Date
FDA to decide on Ionis's zilganersen for Alexander disease by Sept. 22
The priority review rests on a pivotal trial that showed a 33.3% gait-speed benefit over control, a result that would make zilganersen the first approved treatment for the disease.
NCT04849741 - FULL APPROVAL
FDA approves Merck's Keytruda plus Padcev for muscle-invasive bladder cancer
The approval, weeks ahead of its August 17 PDUFA date, rests on a 47% reduction in disease progression or death versus chemotherapy before and after surgery.
NCT04700124 - ACCELERATED APPROVAL
FDA grants accelerated approval to Vera's TRUTAKNA for IgA nephropathy
The approval rests on a 42% proteinuria reduction versus placebo from an interim ORIGIN 3 analysis, making TRUTAKNA the first dual BAFF and APRIL inhibitor cleared for the disease.
NCT04716231 - FULL APPROVAL
FDA approves Orca Bio's Tregzi after Precision-T cut chronic GVHD-free survival gap
The Phase 3 Precision-T trial showed 78% of Tregzi recipients free of chronic GVHD or death at 12 months versus 38% on standard transplant, and the FDA approved the cell therapy days ahead of its July 6 target date.
NCT05316701 - FULL APPROVAL
FDA approves Arcutis's Zoryve cream for plaque psoriasis in children as young as 2
The approval, based on a 4-week pharmacokinetics and safety study, extends Zoryve's label below the age of 6 and marks the drug's seventh FDA nod in four years.
NCT04746911 - FULL APPROVAL
FDA grants full PMA approval to Artivion's AMDS aortic dissection device
The approval eliminates the humanitarian-exemption IRB requirement and rests on PERSEVERE data showing a 72% relative cut in 30-day mortality versus hemiarch repair alone.
NCT05174767 - COMPLETE RESPONSE LETTER
Achieve gets CRL for cytisinicline over manufacturing, not efficacy or safety
The FDA cited third-party manufacturing and labeling issues, not the drug's clinical data, and Achieve plans to resubmit in Q4 2026 with a new manufacturing partner.
NCT04576949 - FULL APPROVAL
FDA approves Bayer's Ambelvist, a lower-dose gadolinium MRI contrast agent
The approval rests on Phase 3 QUANTI data showing lesion visualization at 0.01 mmol/kg comparable to existing agents dosed at twice to five times the gadolinium load.
NCT05915728 - FULL APPROVAL
FDA approves Keytruda plus Welireg as first adjuvant regimen in kidney cancer
The combination cut recurrence or death risk by 28% versus Keytruda alone, the first HIF-2α and PD-1 combination to reach approval in earlier-stage clear cell renal cell carcinoma.
NCT05239728 - FULL APPROVAL
MannKind wins FDA approval for Afrezza in children as young as 6
The approval, backed by the Phase 3 INHALE-1 trial, makes Afrezza the first inhaled mealtime insulin option for pediatric patients after a century of injection-based therapy.
NCT04974528 - COMPLETE RESPONSE LETTER
FDA clears Unicycive's OLC for hyperphosphatemia after 2025 CRL
The FDA accepted Unicycive's resubmitted NDA and set a June 29, 2026 PDUFA date a year after a manufacturing-related complete response letter forced the restart.
NCT06218290