FDA 1 hour ago Trump Backs FDA Push to Fast-Track Psychedelic Treatments Trump has vowed to push FDA to expedite psychedelic drug development. fda
FDA 9 hours ago 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
FDA 2 days ago 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
FDA 2 days ago 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
FDA 3 days ago 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
FDA 3 days ago 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
Deals 4 days ago Aligos Sells China HBV Rights to Amoytop in $445M Deal Aligos Therapeutics sold the Greater China rights to pevifoscorvir sodium to Fujian-based Amoytop for up to $445 million: $25 million upfront and $420… deals
Deals 4 days ago Revolution Doubles Offering to $2B at $142 After Daraxonrasib Phase 3 Win Revolution Medicines is raising $2 billion in a stock offering priced at $142 per share, up from the $1 billion it announced Monday, hours after reporting… deals
FDA 5 days ago 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 5 days ago 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
FDA 6 days ago 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 6 days ago 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
FDA 6 days ago IDEAYA Targets FDA for Darovasertib After Phase 3 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
FDA 6 days ago Ideaya Hits Late-Stage Benchmark for Rare Eye Cancer Drug, Plans Accelerated Filing 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
FDA Apr 13, 2026 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
FDA Apr 13, 2026 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
FDA Apr 13, 2026 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
FDA Apr 13, 2026 FDA Cleared Foundayo; Lilly Pre-Stocked $1.5B Before Approval FDA cleared Foundayo eight days ago, and Eli Lilly was ready: the company pre-stocked $1.5 billion worth of the pill back in February, months before… fda
Deals Apr 9, 2026 BARDA Cut $482m Shionogi Deal for US Antibiotic Capacity BARDA paid $482m to get Fetroja made on US soil. deals
FDA Apr 9, 2026 FDA Sets First Formal Rules for Form 483 Responses FDA issued draft guidance on April 8 giving drug manufacturers their first formal direction on responding to a Form 483, the written list of objectionable… fda
Deals Apr 8, 2026 Gilead Spends $14.77B on Three Deals, Then Hits Pause Gilead bought Arcellx, Ouro, and Tubulis for $14.77B in under ten weeks. CFO says further big deals are unlikely this year, but the door stays open. deals
FDA Apr 8, 2026 Lilly's Foundayo Clears FDA; Novo's Oral Wegovy Holds 5-Point Efficacy Lead Lilly's oral obesity pill approved but trails Novo on weight loss. Pharma's M&A sprint added $7.9B in deals and Trump's tariffs landed with carveouts. fda
FDA Apr 7, 2026 Amgen's Tepezza Just Got Injectable Data. So Did Viridian. Amgen's subcutaneous Tepezza cleared Phase 3 as Viridian Therapeutics competes in the same thyroid eye disease market. Both are racing to file with FDA. fda
FDA Apr 7, 2026 FDA Asks Congress for Market Withdrawal Power Over Manufacturing Gaps FDA's April 3 budget proposal asks Congress for market withdrawal power over postapproval manufacturing gaps and API supplier non-disclosure. fda
Deals Apr 7, 2026 Apnimed Locks $150M Credit Line for AD109 Sleep Apnea Launch Apnimed secured up to $150M from HCRx to launch AD109, with only $50M unconditional and the rest tied to FDA approval and a sales milestone. deals
FDA Apr 6, 2026 ImmunityBio Loses $2B in a Day After FDA Hits 'Cures Cancer' Pitch FDA warned ImmunityBio after Chairman Patrick Soon-Shiong said Anktiva could 'cure cancer' on a podcast. Stock dropped 21%, $2B market cap gone. fda
Deals Apr 6, 2026 Lilly Pays $7.8B for Centessa to Buy Into the Orexin Race Lilly is paying $7.8B for Centessa — $38/share plus a $9 CVR — to grab cleminorexton, a Phase IIa orexin agonist for narcolepsy. deals
FDA Apr 6, 2026 Makary's FDA Gets White House Backing to Fast-Track US Biotech vs. China White House budget backs FDA policy shifts under Makary to speed US clinical trials and cut costs — framed as a direct counter to China's biotech ambitions. fda
Deals Apr 6, 2026 Anthropic Drops $400M on Six-Person Drug Discovery Startup Anthropic acquires six-person AI biotech Coefficient Bio for $400M in stock — $66M per employee for a company founded in 2025 with no public product. deals
Deals Apr 6, 2026 Takeda Walks Away From $150M Denali Dementia Bet After 8 Years Takeda returns frontotemporal dementia drug DNL593 to Denali after 8 years and $150M, citing strategy—not safety—days after Denali's FDA approval win. deals
Deals Apr 6, 2026 Neurocrine Pays $2.9B for Soleno's Prader-Willi Drug Neurocrine pays $53/share in cash for Soleno Therapeutics, acquiring Vykat XR, a profitable approved treatment for Prader-Willi syndrome. deals
FDA Apr 5, 2026 Lipocine's PPD Drug Fails Phase 3, Stock Craters 77% Lipocine's oral brexanolone failed Phase 3 for postpartum depression, wiping 77% off its stock. The pill version of Zulresso didn't work. fda
FDA Apr 5, 2026 Novo Fires Back at Lilly's Foundayo With Competing Efficacy Data Novo Nordisk published rival efficacy data the day after FDA approved Lilly's oral obesity pill Foundayo — but no head-to-head trial exists to back the claims. fda
FDA Apr 5, 2026 Pfizer Scraps COVID Vaccine Trial; 80% of Recruits Failed Screening Pfizer and BioNTech shut down their 25,000–30,000-person COVID trial after 80%+ of recruits failed screening, leaving FDA-required approval data ungenerated. fda
FDA Apr 5, 2026 FDA Clears Novocure's Pancreatic Cancer Device in First-Ever Approval FDA approved Novocure's Optune Pax for locally advanced pancreatic cancer, the first device cleared for it, adding ~2 months to survival over standard chemo. fda
FDA Apr 5, 2026 FDA Clears Novo Nordisk's Higher-Dose Wegovy in 54 Days FDA approved Novo Nordisk's 7.2mg Wegovy HD in 54 days via the CNPV fast-track, handing Novo a pricing lever and leaving insurers to argue the math. fda
FDA Apr 5, 2026 FDA Clears 7.2mg Wegovy HD for Novo Nordisk in 54-Day Sprint FDA cleared Novo Nordisk's 7.2mg Wegovy HD in 54 days under its national priority program, pushing the GLP-1's efficacy ceiling higher. fda
FDA Apr 5, 2026 Lilly's Oral GLP-1 Pill Cleared in 50 Days, Fastest NME Since 2002 Eli Lilly's oral GLP-1 pill orforglipron approved in 50 days under the FDA's CNPV pilot — the fastest new molecular entity approval since 2002. fda
