Browsing Tag
U.S. Food and Drug Administration
105 posts
A small imaging trial could reshape how brain metastases are detected and Radiopharm Theranostics is betting on it (ASX: RAD)
Radiopharm Theranostics reports strong RAD 101 interim data in brain metastases imaging. Discover the strategic and market implications.
Biocytogen just stacked two cancer bets in three days. Is its platform strategy starting to compound?
Biocytogen’s NEOK002 IND clearance and Moonlight Bio deal highlight a platform-led oncology strategy. Read what it means for growth and sentiment.
Atossa Therapeutics (NASDAQ: ATOS) deepens Z-endoxifen bet as 2025 losses widen and rare disease optionality grows
Atossa Therapeutics widened its 2025 loss as Z-endoxifen spending rose and rare disease optionality expanded. Read what this could mean for ATOS.
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.