The abrupt exit of the former CBER director, who quickly made his mark at the agency with several high-profile and ...

The new direct-to-consumer ad signals J&J’s confidence in its capacity to meet demand for the cell therapy after earlier ...

Hong Kong-based CSPC will receive $120 million from Madrigal under the deal. Elsewhere, Apellis and PTC Therapeutics won FDA approvals.

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office ...

The vaccine maker’s board intends to recommend a pending offer from investment firms Nordic Capital and Permira, which would ...

Bristol Myers will get a nearly 20% stake in the startup, which will be led by one of its former executives and advance five ...

Knockoff copies of Novo’s weight loss medicine Wegovy have held back sales and put the drugmaker on the back foot in its ...

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

Leveraging a CDMO’s established platform for AAV manufacturing can significantly streamline gene therapy development.

Facing an end to Keytruda's market exclusivity, the company will cut $3 billion in costs that it plans to redeploy in support ...

Led by former Novartis executive Emanuele Ostuni, the startup has a prostate cancer medicine advancing into early clinical ...