Browsing Tag
U.S. Food and Drug Administration
102 posts
Why YolTech Therapeutics believes YOLT-202 could become a “one-and-done” treatment for Alpha-1 Antitrypsin Deficiency
YolTech Therapeutics receives FDA clearance to launch a Phase 2/3 trial of YOLT-202 for Alpha-1 Antitrypsin Deficiency. Discover what this means for gene editing.
Drug Farm advances DF-003 into FDA rare disease evidence pathway as ROSAH syndrome program enters regulatory dialogue phase
Drug Farm’s DF-003 enters the FDA Rare Disease Evidence Principles Process for ROSAH syndrome. Discover why this regulatory collaboration could shape rare disease drug development.
The operating room’s next AI assistant? Why Perimeter Medical Imaging AI’s Claire approval could matter more than it seems
Perimeter Medical Imaging AI wins FDA approval for Claire, the first AI imaging device for breast cancer surgery. Discover what this means for cancer care and medical AI.
uniQure (NASDAQ: QURE) sinks after FDA mandates Phase III trial for Huntington’s therapy AMT-130
uniQure (QURE) plunges after FDA demands a Phase III trial for AMT-130 in Huntington’s disease. What this means for valuation and next steps.
Does FDA clearance across three HLA subtypes de-risk TScan Therapeutics’ platform strategy?
FDA clears TSC-102-A01 and TSC-102-A03 for TScan Therapeutics. Explore how expanded HLA reach reshapes its heme cell therapy strategy.
Will mavorixafor’s EU path mirror its U.S. regulatory breakthrough in WHIM syndrome?
X4 Pharmaceuticals (NASDAQ: XFOR) wins EMA backing for mavorixafor. Explore what EU approval could mean for revenue, risk, and rare disease strategy.
How FDA-aligned endpoints position inFoods IBS alongside drug therapies
Biomerica, Inc. aligns inFoods IBS with FDA drug endpoints and secures Medicare pricing. See what this means for IBS competitors and investors.
SCY-247 intravenous trial signals strategic shift in SCYNEXIS, Inc.’s antifungal pipeline
SCYNEXIS, Inc. advances IV SCY-247 into Phase 1. Discover what this signals for antifungal resistance and hospital markets.
Neurizon Therapeutics (ASX: NUZ) just crossed the threshold every ALS biotech dreams about. Now the hard part starts.
Neurizon Therapeutics (ASX: NUZ) doses first ALS patient in the HEALEY Platform Trial. What the Phase 2/3 design means for investors and the sector. Read more.
FDA clears Bysanti and suddenly Vanda Pharmaceuticals Inc has no margin for execution failure
FDA approval of Bysanti sends Vanda Pharmaceuticals Inc stock higher. Read why execution now matters more than hype in schizophrenia and bipolar markets.