Myovant and Pfizer’s endometriosis expansion bid for Myfembree has hit a pothole late in the FDA’s review process. In a letter to the companies, the United States …

Down with Rybelsus! No, this isn’t a line from “1984,” but rather the new message from Novo Nordisk for its first Rybelsus ad of 2022. …

It wasn’t supposed to be this way. Zealand Pharma should be in the honeymoon glow of its first drug launch with a drug approved less …

In 2018 with Xyosted, Antares brought to the market a user-friendly testosterone replacement therapy for hypogonadism, with the drug administered at home by weekly injection. …

A few hours after the FDA authorized a fourth dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines, one of its top experts hinted that a …

Moderna has new data backing the use of its COVID-19 vaccine Spikevax at a low dose in the youngest children under the age of 6, …

It’s finally here: After a series of delays in the lead-up to Novavax’s COVID-19 vaccine filing with the FDA, the biotech has completed its emergency …

Last January, when GlaxoSmithKline’s ViiV Healthcare won a long-awaited approval for its long-acting HIV treatment Cabenuva, it was hailed as a game-changer as it removed …

Now poised for a speedy trip through the FDA’s regulatory review, Roche’s oral challenger in spinal muscular atrophy (SMA) could soon pick up a nod …

The FDA blessed Idorsia’s Quviviq (daridorexant), a sleeping pill for those with insomnia. Because the FDA has recommended Idorsia to register Quviviq as a controlled substance, the …