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 — Page 8
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
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…
FDA
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
Bets Five Phase 3 Studies on Hansoh ADC: GSK Targets Gynecological Cancers
GSK is planning five Phase 3 studies for an antibody-drug conjugate it licensed from Chinese partner Hansoh Pharma, targeting gynecological cancers.
FDA
Judge Blocks Trump's ACIP Picks; Kennedy Rewrites Charter
A federal judge suspended most of the Trump administration's appointments to the CDC's Advisory Committee on Immunization Practices, but a newly published…
FDA
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FDA issued draft guidance on April 8 giving drug manufacturers their first formal direction on responding to a Form 483, the written list of objectionable…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
Merck Reworks Zhifei China Vaccine Deal
Merck renegotiated its China vaccine supply agreement with distribution partner Zhifei.
FDA
Lilly Foundayo Clears FDA; Novo's Oral Holds 5-Point 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
Novo Nordisk's 7.2 mg Wegovy Hits US Shelves at Triple the Standard Dose
Novo Nordisk's 7.2 mg Wegovy is now available in the US, tripling the standard 2.4 mg dose in a direct bid to reclaim ground lost to Lilly's Zepbound.
FDA
TrumpRx Lists AbbVie's Humira at $950/Month Next to Cheaper Biosimilars
White House added Humira to TrumpRx at $950/month, the same site that already lists cheaper Pfizer and Amgen biosimilars.
FDA
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 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
Lunsekimig Fails Eczema Phase 2, Leaving Dupixent Without a Successor
Sanofi's lunsekimig cleared asthma and nasal polyp trials but failed its eczema Phase 2, leaving Dupixent without a clear successor as its patent cliff nears.
FDA
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
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.
