As the calendar turned from April to May, a big change came to the FDA. | Katherine Szarama, Ph.D., will take over as CBER ...

Viking Therapeutics’ collaboration with Ligand Pharmaceuticals has sailed into some trouble, with one of the partners keen to ...

Johnson & Johnson has dropped a pair of CAR-T cell therapies, axing programs it once predicted could deliver peak sales north ...

Danish dermatology specialist Leo Pharma is paying $50 million for U.S. gene writing biotech Replay and its preclinical gene ...

Amgen has pulled the plug on midstage drug candidates for cancer and the autoimmune disease Sjögren’s syndrome, terminating ...

The FDA’s Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 6 to 3 that AstraZeneca has not demonstrated its oral ...

The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with ...

A phase 2 trial of Indivior Pharmaceuticals’ opioid use disorder (OUD) candidate has missed its primary endpoint. Indivior ...

Bristol Myers Squibb has called time on a bispecific antibody partnership with Zymeworks that the Big Pharma inherited from ...

Avalyn Pharma has overshot its expectations with a $300 million IPO that the biotech will use to fund late-stage studies of ...

BeOne Medicines is paying $20 million upfront to reserve the right to buy a preclinical trispecific antibody from China’s ...

GSK and Alector have stopped a phase 2 trial of their Alzheimer’s disease drug candidate after an interim analysis found the ...