Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

The deal could expand access to its in-demand obesity drug at the expense of Eli Lilly, whose shares fell by double digits on ...

Drugmaker executives have projected confidence they can mitigate the impact of any levies Trump imposes on the industry. Yet ...

The company removed experimental drugs for Alzheimer’s, migraine and pain from its pipeline to focus more resources on “core ...

Arvinas is laying off about a third of its workforce, while Entrada is focusing more on Duchenne research. Elsewhere, Biogen ...

Siren Biotechnology is trying to raise $5 million via the type of crowdfunding round that’s rarely used by young drugmakers.

The company has predicted that Imaavy — now approved for myasthenia gravis — could eventually earn more than $5 billion in ...

Deals with Hims & Hers, LifeMD and Ro follow dismissal of a lawsuit that challenged the FDA's determination Wegovy is no ...

Zevaskyn, which Abeona priced at $3.1 million, treats epidermolysis bullosa. It will compete with a gene therapy from Krystal ...

The company’s CEO said he’s had “productive discussions” with Trump administration officials on a recently launched trade ...

The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...