The FDA is currently reviewing Merck’s sBLA for Keytruda in head and neck cancer, with a target action date of June 23.

With ivonescimab’s data coming solely from China, its prospects in the U.S., where Summit owns the rights, remain up in the ...

DELFI Diagnostics has clinically validated FirstLook Lung, its blood test designed to improve early detection of lung cancer, ...

As tariffs, HHS workforce cuts and the ouster of CBER Director Peter Marks threaten the “lifeblood” of the cell and gene ...

While AbbVie handily beat expectations this quarter, the company faces declining Humira sales and a challenged aesthetics ...

The cell and gene therapy company is cutting 47 employees and its entire lupus program to focus resources on two CAR Ts. The ...

As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering ...

Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment ...

Big compounders will have until May 22 to stop producing and dispensing compounded semaglutide, while smaller, state-run ...

The hold, placed by the FDA on an early-stage clinical trial of an experimental BET inhibitor, stems from a recent ...

The transaction, which sources say could be agreed upon as soon as Monday, would price SpringWorks at $47 per share, totaling ...

The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its ...