FDA
Gilead Cuts Arcus Ties After Domvanalimab Phase 3 Failure
Domvanalimab has failed its pivotal phase 3 trial in untreated metastatic non-small cell lung cancer, and Gilead Sciences is stepping back from its…
FDA — Page 4
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
FDA
Trump EO Cuts Psychedelic Reviews, Compass Jumps 25%
Trump signed an executive order Saturday directing FDA to issue Commissioner's National Priority Vouchers (CNPVs) to psychedelic drugs with breakthrough…
FDA
Trump Backs FDA Push to Fast-Track Psychedelic Treatments
Trump has vowed to push FDA to expedite psychedelic drug development.
FDA
Wins Third Phase 3 in COPD: AstraZeneca's Tozorakimab Eyes $5B Peak
Tozorakimab now has three phase 3 COPD wins in 2026.
FDA
Novo Targets FDA Filing for Etavopivat After 27% VOC Reduction
Etavopivat cut vaso-occlusive crisis rates by 27% in a 385-patient phase 3 trial, and Novo Nordisk is now targeting an FDA submission in the second half of…
FDA
RevMed Doubles Phase 3 Survival With Pan-RAS Drug at AACR25
Revolution Medicines' pan-RAS inhibitor delivered a landmark Phase 3 survival readout at AACR25 that doubled survival, setting off what the oncology field…
FDA
Merck Hits 55% NSCLC ORR With MK-2010, Won't Commit to Phase 3
Merck's MK-2010 posted a 55% unconfirmed overall response rate among 11 previously untreated PD-L1-positive non-small cell lung cancer patients, the first…
FDA
Rejected Twice: Replimune's RP1 and the 22 Scientists Who Disagreed
FDA rejected Replimune's RP1 for advanced melanoma for the second time on April 10, citing the same reason it cited last July: heterogeneity of the…
FDA
Recalled: Viatris Xanax Lot, Teva's 7 Clonidine Batches
FDA graded two separate recalls Class II this week: Viatris pulling extended-release Xanax over failed dissolution specs, Teva yanking clonidine patches…
FDA
FDA Cleared Foundayo With 3 Postmarketing Safety Study Requirements
FDA cleared Foundayo, Eli Lilly's oral GLP-1 pill for obesity, on April 1, but the approval letter lists three postmarketing requirements tied to what the…
FDA
FDA Cleared Filspari for FSGS; Travere Eyes $3B U.S. Peak
FDA cleared Filspari for focal segmental glomerulosclerosis on Monday, handing Travere Therapeutics a fresh shot at what it values as a more than $3 billion…
FDA
Doubles PDAC Survival: Revolution Jumps 40% on Daraxonrasib Phase 3 Data
Revolution Medicines shares jumped to $134.80 Monday, up nearly 40%, after daraxonrasib delivered overall survival of 13.2 months in metastatic pancreatic…
FDA
FDA Cleared Filspari for FSGS Despite Phase 3 Fail, Opening $2B Market
FDA cleared Filspari for focal segmental glomerulosclerosis on Monday, making Travere Therapeutics' endothelin blocker the first and only approved drug for…
FDA
IDEAYA Files FDA: Darovasertib Doubles PFS to 6.9 Months
Darovasertib, IDEAYA Biosciences and Servier's PKC inhibitor for metastatic uveal melanoma, more than doubled median progression-free survival in its Phase…
FDA
Ideaya Eye Cancer Drug Hits Phase 3, Files Accelerated NDA
Ideaya Biosciences cleared its own late-stage success benchmark for a rare eye cancer drug, and the company now plans to file for accelerated approval with FDA.
FDA
Beats Venetoclax: Lilly's Jaypirca Posts 4th Phase 3 Win in CLL
Jaypirca chalked up its fourth positive phase 3 readout in chronic lymphocytic leukemia on Monday, and this one rewrites the treatment calculus: it's the…
FDA
Revolution Medicines' Daraxonrasib Succeeds in Phase 3 Registrational Trial
Daraxonrasib succeeded in a Phase 3 registrational trial for pancreatic cancer patients, Revolution Medicines reported Monday.
FDA
Cleared Phase 3: Daraxonrasib Hits 13.2-Month OS in Pancreatic Cancer
Daraxonrasib cleared both primary endpoints in a phase 3 trial for previously treated metastatic pancreatic cancer, Revolution Medicines reported April 13.
FDA
Darovasertib Hits 6.9-Month PFS Goal, Ideaya Plans H2 FDA Filing
Darovasertib cleared its primary endpoint in a phase 2/3 trial in metastatic uveal melanoma, posting median progression-free survival of 6.9 months against…
FDA
GSK Races mo-rez Into 5 Phase 3 Trials After 62% Ovarian ORR
GSK is sending mocertatug rezetecan (mo-rez) into five phase 3 trials after phase 1b data posted a 62% confirmed overall response rate in platinum-resistant…
