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 ...

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 ...

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 ...

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

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

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

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