Browsing Tag
U.S. Food and Drug Administration
129 posts
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.
Could D-PLEX100 turn surgical infection prevention into a breakout story for PolyPid?
PolyPid’s Azurity deal gives D-PLEX100 a U.S. and Canada launch path, with PYPD investors watching FDA acceptance and 2027 approval timing.
Samsung’s new Galaxy watches promise deeper health insights, but can they revive its wearable momentum?
Samsung Electronics is positioning the Galaxy Watch Ultra2 and Galaxy Watch9 as continuous health platforms, combining longer battery life, new cardiovascular and recovery insights, and a clearer split between everyday wellness and specialist outdoor performance.
Could three FDA submissions turn bezuclastinib into a rare disease and oncology launch engine?
Cogent’s AdvSM NDA gives COGT a third bezuclastinib FDA submission, sharpening its KIT-driven disease franchise and late-2026 launch story.
Could nomlabofusp become the rare disease catalyst that revalues Larimar?
Larimar’s rolling BLA and nomlabofusp data sharpen LRMR’s rare disease biotech story around Friedreich’s ataxia, frataxin and accelerated approval.
Why CGTX stock could draw attention after FDA alignment on DLB psychosis
Cognition Therapeutics’ FDA alignment gives zervimesine a clearer DLB psychosis path, sharpening CGTX’s dementia drug development and stock story.
Otsuka Holdings expands neuropsychiatry strategy with $1.23bn Transcend deal structure
Find out how Otsuka’s Transcend Therapeutics acquisition could reshape PTSD drug development and investor sentiment around TSE: 4578.
How a first-in-class HDV approval could support Gilead Sciences’ long-term antiviral portfolio
Find out how Hepcludex approval could strengthen Gilead Sciences’ antiviral portfolio and reshape HDV care in the U.S.
Could engineered pig hearts become the next major frontier in biotechnology investing?
Find out how United Therapeutics’ FDA-cleared UHeart trial could reshape engineered organ transplants and investor expectations.
Aldeyra Therapeutics brings biotech CFO experience to board amid ALDX regulatory reset
Find out how Aldeyra Therapeutics’ new board appointment could shape ALDX stock sentiment, FDA strategy and reproxalap’s next chapter for investors now.