Browsing Tag
FDA
340 posts
Avacta just won a clean FDA path to full AVA6000 approval, so why did $AVCT barely move?
Avacta won a clean FDA path to full AVA6000 approval, yet AVCT (AIM) barely moved. The real question is whether a partner signs before cash runs low.
Butterfly Network (NYSE: BFLY) AI ultrasound thesis meets the Home Care launch test
Butterfly Network (NYSE: BFLY) beat Q1 with 25% growth, 69% margins and a Midjourney deal. The Home Care launch in Q3 is the next real test.
Abivax (NASDAQ: ABVX) obefazimod NDA path meets a safety debate the market is still pricing
Abivax (NASDAQ: ABVX) put up Rinvoq-like ulcerative colitis remission data and dropped 40 percent. The question is whether the malignancy debate sticks.
uniQure surges 78% as FDA clears accelerated approval path for its Huntington’s disease gene therapy
uniQure (QURE) surges 78 percent as FDA clears accelerated approval path for AMT-130 in Huntington's disease, with BLA filing due Q3 2026. Full analysis.
Moderna rallies into a landmark FDA advisory vote on its mRNA seasonal flu vaccine
Moderna (MRNA) rallies as an FDA advisory committee weighs its mRNA seasonal flu vaccine mFlusiva, the first such vote, with a decision due August 5. Full analysis.
uniQure (QURE, NASDAQ) targets Q3 BLA after FDA’s Huntington’s reversal
The FDA spent months blocking uniQure's Huntington's gene therapy. Now it wants the filing in Q3. QURE doubled, but approval is still unwon.
Sanofi (SNY) wins a pivotal Tzield label expansion into recently diagnosed stage 3 type 1 diabetes
Sanofi (SNY) wins FDA accelerated approval for Tzield in recently diagnosed stage 3 type 1 diabetes, expanding its market beyond screening. Full analysis here.
Why Amgen’s Tavneos trouble may be more than just another FDA safety review
Find out why Amgen’s Tavneos review could reshape rare disease drug regulation, investor sentiment, and biotech M&A risk.
Why Enliven’s FDA alignment may matter as ELVN-001 moves toward Phase 3
Find out how Enliven’s ELVN-001 data and FDA alignment could reshape the next phase of chronic myeloid leukemia therapy.
Humacyte (HUMA) posts positive Phase 3 dialysis access data, then raises $50m at a discount on the strength of it
Humacyte (HUMA) posts positive Phase 3 dialysis access data and raises $50M at a discount. FDA filing planned for H2 2026. Read the full executive analysis.