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 will take place amid newly imposed scrutiny of COVID shots.

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

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 ...

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 ...

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 ...

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

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

The FDA pushed back its decision date on Cytokinetics’ heart drug. Elsewhere, Repare Therapeutics licensed its drug discovery ...

The firm, a prolific backer of drug startups, will use the cash to back companies working on therapeutics, medical devices ...