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 — Page 5
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
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FDA issued draft guidance on April 8 giving drug manufacturers their first formal direction on responding to a Form 483, the written list of objectionable…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.
FDA
Amgen's $27.8B Drug Gets Easier — Tepezza Shot Matches IV
Amgen's phase 3 shows subcutaneous Tepezza via on-body injector hits 77% response rate, matching IV efficacy, potentially expanding the flat $1.9B drug's reach.
FDA
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
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
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
White House Asks for $15.8B HHS Cut — Congress Already Said No Once
White House requests $15.8B HHS cut for FY2027, including a $5B NIH reduction and three institute eliminations. Congress rejected a bigger ask last year.
FDA
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 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.
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