Browsing Tag
U.S. Food and Drug Administration
132 posts
Perimeter Medical Imaging AI places Claire at hospitals while recurring legacy revenue rises 31%
Perimeter Medical Imaging AI improved Q2 operating performance and began deploying its FDA-approved Claire system, although all $503,000 of quarterly revenue still came from its legacy S-Series business.
Fulcrum Therapeutics agrees reverse merger with Slate Medicines and $270m dividend
Fulcrum's $270m dividend and 5% stub hand Slate a Nasdaq listing, but SLTE-1009's PACAP bet must beat CGRP incumbents to justify a $350m valuation.
NIH backs Greenstone Biosciences iPSC and AI programme for Duchenne cardiomyopathy
Greenstone Biosciences has secured a National Institutes of Health R61 award to discover potential treatments for cardiac fibrosis and dilated cardiomyopathy in Duchenne muscular dystrophy, extending its patient-derived stem-cell drug discovery strategy into one of the disease’s most consequential complications.
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.