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 ...

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 ...

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 ...

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 ...

Shanghai Ailux Biotechnology Co. Ltd. and Ailux Inc. have presented preclinical data regarding the characterization of ...

PD-1 and LAG-3 are both inhibitory immune checkpoints known for limiting T cell activity in cancer. Blocking PD-1 and LAG-3 ...

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.