Shortages of Ozempic and Wegovy that have been in place for more than two years have been resolved, as supplies of obesity ...

FDA drug alerts in endocrinology, including drug approvals, drug warnings, FDA medical device recalls, and FDA drug label ...

Several rare disease patient populations received their first-ever FDA-approved drug since Rare Disease Day last year, ...

ITF, IntraBio and Orchard are among the companies that have won FDA nods in the past year for Duchenne muscular dystrophy, ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.

Dog owners can anticipate a new anti-aging pill that has achieved a key FDA milestone for efficacy, with expected market ...

The U.S. Food and Drug Administration said on Friday it issued new labeling changes for testosterone products based on ...

As we observe Rare Disease Day today, let us take a look at seven drugs poised to be approved to address rare diseases in ...

For example, the Pixel Watch, Apple Watch, and others can detect atrial fibrillation (AFib), a type of irregular heartbeat ...

Mirum gained the drug, which it will sell as Ctexli for adults with cerebrotendinous xanthomatosis, in a 2023 deal with ...

The start-up Loyal developed a pill to extend dogs’ lifespan that has been recognized by the FDA as having “reasonable ...