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 ...

A progressive approach to drug approval would balance the reality of drug safety and efficacy research with the desire to get ...

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

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

The FDA expanded the approval of a sublingual immunotherapy (SLIT; Odactra) for treating house dust mite allergies in young ...

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

Chenodiol -- a naturally occurring human bile acid also known as chenodeoxycholic acid -- is the first FDA-approved drug indicated for the rare lipid storage disease and autosomal recessive ...

One in six patients in phase II oncology clinical trials received a treatment that was eventually approved by the FDA, ...

The FDA has announced that the shortage of Wegovy and Ozempic, medications used for weight loss and diabetes management, is ...

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

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