A month ahead of its June 5 PDUFA date, Arvinas Inc.’s vepdegestrant gained U.S. FDA approval for use in a specific type of advanced or metastatic breast cancer, becoming the first proteolysis ...
Axsome Therapeutics Inc. won U.S. FDA approval for Auvelity (AXS-05) to treat Alzheimer’s disease agitation, a condition that ...
Following a discussion today that focused more on the unique personalized trial strategy rather than the benefits of the therapy, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3-6 ...
The memory of Merck & Co. Inc.’s $10 billion takeover last year of inhaled respiratory drug specialist Verona Pharma plc may not have been far from the minds of Wall Street speculators as Avalyn ...
Beone Medicines Ltd. gained an exclusive option to develop cancer immunotherapy HH-160 worldwide in a deal potentially worth ...
Dermatology specialist Leo Pharma A/S is moving into gene therapy with the $50 million acquisition of Replay Holdings LLC, a seed-stage company that is developing high capacity herpes simplex virus ...
The U.S. SEC filed a settlement April 29 that it reached with Anthony Cataldo regarding allegations that the former chairman and CEO of a clinical-stage biopharma company misappropriated about $3.2 ...
The European Medicines Agency (EMA) has launched a pilot program to fast track breakthrough medical devices in the EU and get ...
The U.S. Department of Health and Human Services (HHS) has appealed a recent federal ruling that put on hold several changes to the childhood vaccine schedule and the Advisory Committee on ...
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Candel, Circular, Emalex, Eversana, Greywolf, Infinite, Pfizer, Psyga, Teva, XTL.
After a standout 2025, the BioWorld Cancer Index (BCI) started 2026 on more measured footing. Early volatility this year saw the BCI drop 11.51% by the end of January before recovering to post a ...
Shanghai Ailux Biotechnology Co. Ltd. and Ailux Inc. have presented preclinical data regarding the characterization of ...
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