FDA
Replimune cuts 224 jobs after FDA's second RP1 rejection
FDA rejected Replimune's RP1 for advanced melanoma a second time, and 224 Massachusetts employees are now paying for it.
FDA — Page 7
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
FDA
NC Biotech Gathers CAR-T Crowd at UNC Friday After $7B Kelonia Deal
CAR-T makers hit UNC Chapel Hill Friday, five days after Lilly's $7B Kelonia bet turned the CMC question into the deal question.
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FDA
Roche MS Pill Doubles Relapse-Free Time, Flags Liver Risk
Roche's multiple sclerosis pill more than doubled patients' relapse-free intervals compared with Sanofi's marketed MS pill Aubagio, according to data…
FDA
Carvykti shows promise in all 20 smoldering myeloma patients
All 20 patients with high-risk smoldering multiple myeloma showed results with Carvykti in a Dana-Farber Cancer Institute study, researchers reported.
FDA
Failed: Merck's Welireg Combo in First-Line Kidney Cancer
Merck's combination of Welireg and Keytruda failed to deliver a significant improvement in newly diagnosed patients with advanced kidney cancer, the company…
FDA
Novartis Cuts 2 Late-Stage Programs on Inferior Efficacy Data
Novartis axed two late-stage programs targeting cancer-related blood clots after observing "inferior efficacy" in a clinical trial, the company confirmed.
FDA
Signed April 18: Trump EO Cuts Psychedelic Reviews to 1-2 Months
FDA will issue Commissioner's National Priority Vouchers to psychedelic Breakthrough Therapy drugs, including Compass Pathways' COMP360 psilocybin program…
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
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…
