The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin ...

The bispecific antibody helped people with small cell lung cancer live longer, Amgen said. Elsewhere, J&J shared new autoimmune drug data and Alzheon reported an Alzheimer’s drug failure.

Experts say the layoffs are already causing issues in drug development — and things may get far worse without critical ...

Drug company shares, which had sunk on comments by Trump that pharma duties would be coming soon, rallied along with the ...

Shares in many large drugmakers initially fell Wednesday on the president's threat, only to rebound later when he announced a ...

In its first full year on the U.S. market, bladder cancer treatment Adstiladrin earned about $77 million. Elsewhere, Lilly ...

Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S.

La., had invited Kennedy to testify April 10 on the sweeping layoffs of federal health workers Kennedy ordered last month. A ...

Reduction-in-force notices went out Tuesday morning to employees across HHS. At FDA, OND director Peter Stein is departing as ...

Cellular Therapies and IDRx, crossed the $1 billion mark, a notable decrease from the six seen during the same period last ...

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed ...