Novartis expects the new capacity will allow it to produce all of its key medicines “end to end” in the U.S., as the Trump ...

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

Universities are waiting cautiously as the agency's unilateral plan to cut billions of research support dollars has already ...

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

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

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

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

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

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

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.

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...

The sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions ...