Browsing Tag
U.S. Food and Drug Administration
129 posts
BeOne Medicines wins FDA Priority Review for TEVIMBRA in HER2-positive GEA as ONC stock faces trial-to-approval test
BeOne has survival data and FDA momentum. The bigger question is whether TEVIMBRA can change first-line HER2-positive GEA care.
Medtronic expands cardiac ablation ambitions as Sphere-9 gains FDA Breakthrough Device pathway for VT
Medtronic’s Affera push is no longer just an AFib story. VT data may decide whether Sphere-9 becomes a broader ablation platform.
Abbott (NYSE: ABT) showcases four HRS 2026 trials as cardiac rhythm market competition intensifies
Abbott has fresh arrhythmia data, but its stock sits near yearly lows. Can cardiac innovation reset investor confidence?
Why clinicians are watching SkinJect as a potential alternative to repeated Mohs surgery
Find out how SkinJect could challenge repeated Mohs surgery and reshape basal cell carcinoma care. Read the full analysis now.
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.