At an event on Monday, the agency officially unveiled long-awaited draft guidance meant to help speed the development of bespoke treatments for extremely rare diseases.

Shares fell by more than 15% on results showing study participants receiving Novo’s CagriSema lost less weight than those who took Lilly’s Zepbound.

Ahead of the looming loss of Keytruda’s exclusivity, the company is creating a standalone, cancer-focused unit and a second business housing its other drugs and vaccines.

The acquisition bolsters Gilead’s sputtering cell therapy business with a medication the company expects to become a ...

In a 6-3 decision, the court rejected President Trump's claim that a 1977 law gave him the authority to impose broad tariffs ...

Shares in the company lost about half their value in Friday trading after use of the test wasn’t associated with a statistically significant reduction in late-stage cancer diagnoses.

The agency could by late December approve a therapy that Roche sees as potentially becoming a new treatment standard for ...

Madrigal shares fell 11% despite again topping consensus sales numbers. Elsewhere, Daiichi Sankyo named a new research chief ...

The new duties will go into effect Feb. 24, although the president has since signaled he will raise the rate to 15%.

Despite a wave of AI-fueled layoffs, the pharma and biotech industries could be spared from massive cutbacks for now.

Led by Brett Giroir and GSK’s ex-chief medical officer, Altesa is advancing a medicine that’s changed hands multiple times and once failed a study in asthma.

In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development ...