The maker of Ozempic and Wegovy expects lower sales and profit growth this year despite recent victories against compounders.

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...

The Food and Drug Administration should look for ways to streamline regulations on new U.S. drug manufacturing facilities to ...

Experts say market turmoil has made it harder for buyers and sellers to agree on price, which can be an especially imposing ...

A vocal opponent of his predecessor Peter Marks, Vinay Prasad will now lead the office tasked with reviewing some genetic ...

While updated study results confirmed the drug lowers a target protein, the therapy's effect on clinical outcomes was less ...

The cuts to three advanced drug programs were “inevitable” given the company’s “unsustainable cash burn,” one analyst wrote ...

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

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

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

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

Bluebird urged shareholders to back a take-private deal that could close imminently. Elsewhere, Unity Biotechnology began a strategic review and Mersana announced plans to cut more than half its ...