Browsing Tag
U.S. Food and Drug Administration
166 posts
Fractyl Health just hit a pivotal endpoint. Why is it cutting 45% of its workforce?
Fractyl Health is eliminating roughly 45% of its workforce and ending internal Rejuva development despite positive pivotal Revita data, concentrating a shrinking cash runway around one obesity programme and a late-2026 FDA filing.
Odyssey Therapeutics targets major inflammatory bowel disease opportunity with oral OD-001
Odyssey Therapeutics stock rises on OD-001 ulcerative colitis results. Explore its $433M cash position, clinical trials and growth prospects.
BioVie stock tumbles 9% despite promising Parkinson’s drug results as Phase 3 financing concerns loom
BioVie stock falls despite promising bezisterim Parkinson's data. Explore the Phase 3 opportunity, financing risks and investor outlook
RAPP stock gains on RAP-219 clinical success as Wall Street weighs modest treatment benefit
Rapport Therapeutics' RAP-219 trial lifts RAPP stock as investors weigh its bipolar mania potential. Discover the Phase 3 outlook and market risks.
First Tracks Biotherapeutics delivers major ANB033 trial win as celiac drug competition intensifies
First Tracks Biotherapeutics stock jumps on positive ANB033 celiac disease trial data. Discover what the results mean for investors and its growth outlook.
Jazz Pharmaceuticals closes $820m Actio Biosciences deal to deepen epilepsy pipeline
Jazz Pharmaceuticals buys Actio Biosciences for $820 million upfront, betting on ABS-1230 while early-stage clinical risk remains the key test.
Telix wins Pixclara approval as first U.S. FET-PET agent opens brain cancer market
Telix has secured FDA approval for Pixclara, the first U.S.-approved FET-PET imaging drug for glioma, converting a 2025 Complete Response Letter into a new brain-cancer diagnostics franchise.
LUMA Vision clears FDA hurdle as VERAFEYE targets an early 2027 U.S. launch
LUMA Vision has secured expanded FDA clearance for VERAFEYE, combining real-time 3D cardiac anatomy, catheter tracking and ablation guidance ahead of a planned commercial launch in early 2027.
Scholar Rock (NASDAQ: SRRK) wins FDA approval for ISEMBYLD in spinal muscular atrophy
Scholar Rock has secured its first U.S. Food and Drug Administration approval with ISEMBYLD, moving from a pre-revenue biotechnology company into commercial execution as analysts model a multibillion-dollar opportunity in spinal muscular atrophy.
Bayesian Health clears the reimbursement hurdle after FDA win for continuous sepsis AI
Bayesian Health has secured Medicare NTAP reimbursement for its FDA-cleared sepsis monitoring software across roughly 739 inpatient DRGs, but the maximum additional payment is only $61.84 per eligible discharge.