FDA
Boosts $6B case for Insmed's TPIP
Guggenheim floats a $6 billion peak for Insmed's inhaled PAH drug, but Truist says the dosing data doesn't back the differentiator yet.
FDA — Page 2
FDA actions, warning letters, CRLs, approvals, and regulatory enforcement.
FDA
Forces PBMs to Prove Every Rebate in 30 Months
Spreadsheets won't cut it anymore: PBMs must now prove, claim by claim, how every rebate and price spread was calculated under the 30-month deadline.
FDA
GSK Drops $2B Cough Drug After Trial Split
GSK just wrote off a chunk of its $2B Bellus buy, admitting camlipixant "is unlikely to transform patient care" after a split Phase 3 readout.
FDA
Cleared Celcuity's Revtorpyk, Stock Jumps 7%
FDA cleared Celcuity's PI3K/mTOR inhibitor for breast cancer, sending shares up 7% and reviving buyout chatter for a one-drug biotech.
FDA
Ditches Tominersen; Roche's Exit Lifts Wave's ASO
Roche just killed a 16-month Huntington's trial after hitting every biomarker target and missing on outcomes. Wall Street already picked its heir.
FDA
Fights FDA Withdrawal, Amgen Defends $459M Tavneos
NEJM retracted the pivotal trial behind Tavneos's FDA approval, and Amgen is still fighting the withdrawal ahead of a July hearing.
FDA
Probes Lilly's China Trials, Deadline July 17
A House China Committee letter gives Eli Lilly until July 17 to explain trials run inside Chinese military hospitals and Xinjiang.
FDA
FDA Hits Sanofi's Genzyme With Second Warning Letter
Sanofi's Genzyme unit racked up its second FDA warning letter in under two years, this time tied to hemophilia drug Altuviiio and Thymoglobulin.
FDA
FDA Sets July 29 Adcomm for Capricor Deramiocel BLA
Capricor just got an FDA adcomm on deramiocel it didn't see coming, one year after Prasad pulled the last one off the Federal Register in real time.
FDA
WHO Deploys Gilead, Mapp Antivirals After 277 DRC Deaths
Gilead's remdesivir and Mapp's MBP134 enter their first DRC trial against Bundibugyo ebolavirus, where 277 have died and no licensed treatment exists.
FDA
Cut 17%: ADC Therapeutics After 27 Zynlonta Deaths
Twenty-seven deaths in Zynlonta's Phase 3 confirmatory trial wiped out 66% of ADC Therapeutics' market cap and 17% of its workforce.
FDA
FDA Cited Jubilant for Six-Month Mold Investigation Lag
When a cleanroom operator's neck swab came back at 83 colony-forming units, Jubilant's sterile plant had already been sitting on the trend for months.
FDA
Failed: Exelixis' Zanzalintinib NLM Endpoint; Dec. 3 PDUFA
Exelixis' zanzalintinib missed OS in the NLM subgroup, putting roughly half of a $1.3B peak-sales estimate at stake before the Dec. 3 FDA call.
FDA
Definium DT120 Clears Phase 3 MDD; Stock +50%
LSD-based DT120 beat placebo by 8.1 MADRS points and held the gain through week 12. Definium's FDA submission just got a lot more credible.
FDA
Warned: Zoll Counted 27 Complaints, FDA Found 50
Zoll labeled its 731 ventilator hazard life-threatening, classified the likelihood as remote. FDA's April warning letter found 23 missing complaints.
FDA
Denali Sells Avlayah PRV for $195M
Denali pockets $195M from its Hunter syndrome voucher, nearly topping Jazz's January record as the restored PRV program recalibrates.
FDA
Cleared 9-0: Moderna mFluvisa Puts $1B in Play
FDA adcomm voted 9-0 for Moderna's mFluvisa after Prasad's RTF letter threatened a $1B revenue opportunity and the 2028 breakeven goal.
FDA
Neumora Cuts 35% After Navacaprant Fails Third Phase 3
Navacaprant scored numerically below placebo in its third Phase 3 try, wiping out half Neumora's market cap and 35% of its staff in one morning.
FDA
Amylyx Eyes Avexitide NDA After Relyvrio Crash
Amylyx's avexitide NDA race for post-bariatric hypoglycemia comes two years after an 80% stock crash wiped out roughly 70% of its workforce.
FDA
CMS Files Permanent Rule for 20-Drug Cycle in 2029
CMS proposes codifying Medicare drug price talks into regulation, targeting 20 more drugs in 2029 — harder for the next administration to reverse.
