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Biotech & Pharma Insights

Expert analysis on FDA approvals, clinical trials, PDUFA dates, and biotech investing strategies

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Clinical Readouts
Clinical Readouts4 min read

MN-166 in ALS: Phase 2 and 3 Readouts Oct 19, 2026

MN-166's Phase 2 readout is set for April 2027, with a -58.8% run-up. We analyze the implications for investors and the upcoming clinical trial results....

FDA & PDUFA Calendar
FDA & PDUFA Calendar20 min read

FDA Calendar Q4 2026: Key PDUFA Dates and Upcoming Approvals

Q4 2026 FDA calendar: all 43 PDUFA dates and FDA decisions through March 2027, with the modeled odds of approval for every drug. Next: bepirovirsen, October 26....

FDA & PDUFA Calendar
FDA & PDUFA Calendar5 min read

BIOA APJ program: Biotech Catalysts Oct 19, 2026

HUMA's ATEV for hemodialysis in female patients has a PDUFA on Oct 22, 2026. Explore other key biotech catalysts to watch in our latest analysis....

FDA & PDUFA Calendar
FDA & PDUFA Calendar5 min read

FDA Calendar October 2026: Key PDUFA Dates and Insights

On October 26, 2026, bepirovirsen could reshape chronic hepatitis B treatment. Explore our analysis of pivotal FDA approval dates this month....