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 — Page 9
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
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.
fda
FDA
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
Trump's 100% Pharma Tariff: Who Pays, Who Gets Out
Trump's 100% tariff on branded pharma imports creates a hard deadline: cut MFN pricing deals and reshore, or face full tariffs by 2030.
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