Browsing Tag
FDA
340 posts
Novartis wins FDA nod for Pluvicto in hormone-sensitive prostate cancer, nearly doubling its addressable pool
FDA's mHSPC label nod nearly doubles Pluvicto's addressable pool. Novartis' five RLT plants and payer coverage now decide how fast $651M Q2 sales scale.
Boston Scientific (BSX) Q2 2026 beats estimates as MiRus TAVR investment reshapes strategy
Boston Scientific lifted FY 2026 guidance and disclosed a $1.5B MiRus TAVR bet, but BSX trades near 52-week lows as softer Q3 growth guidance stings.
Corbus Pharmaceuticals (NASDAQ: CRBP) lands FDA clearance for TEMPO-1 as CRB-701 enters Phase 3
CRB-701 delivered a 42.9% ORR in 2L OPSCC. Corbus Pharmaceuticals must now reproduce it in a 250-patient TEMPO-1 trial that starts enrolling in September.
Eli Lilly (NYSE: LLY) to acquire AtaiBeckley in $3.8bn TRD psychedelic deal
Eli Lilly (NYSE: LLY) to acquire AtaiBeckley for $6.75/share cash plus $2.50 CVR, taking the BPL-003 5-MeO-DMT depression asset to Phase 3 read in 2029.
Avacta (AIM: AVCT) just paid down £3.67m of bond debt in cash. The real question is what AVA6103 does next.
Avacta cleared bond debt in cash and reaches its AVA6103 readout on funded runway. The next six months decide whether pre|CISION reads as one drug or a platform.
Rhythm Pharmaceuticals (RYTM) TRANSCEND trial in NEJM shows 19.8% placebo-adjusted BMI reduction
Rhythm Pharma (RYTM) TRANSCEND Phase 3 published in NEJM validates IMCIVREE for acquired hypothalamic obesity. 10,000-patient US market launch trajectory ahead.
Catheter Precision (VTAK) rallies 122% on new patents and Flyte 1,000 user milestone
Catheter Precision (VTAK) rallies 122% as two new patents and Flyte hits 1,000 users boost pivot story. Going concern warning still shadows the rally.
Viridian Therapeutics (VRDN) challenges Amgen’s Tepezza with broader thyroid eye disease approval
Viridian Therapeutics wins FDA approval for Lumvoa, its first commercial product, challenging Amgen in thyroid eye disease.
Vertex Pharmaceuticals (Nasdaq: VRTX) gains FDA approval to expand Casgevy to children as young as two
Vertex Pharmaceuticals wins FDA approval to expand Casgevy to children as young as two, reshaping sickle cell treatment economics.
Philip Morris (NYSE: PM) wins first-ever FDA MRTP order for Zyn nicotine pouches
FDA grants Philip Morris (PM) first-ever MRTP orders for 20 Zyn variants, authorizing reduced-risk marketing vs cigarettes. Category shift starts here.