The US Food and Drug Administration (FDA) approved 126 innovator and biosimilar drugs in 2024, significantly lower than the ...

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 ...

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, ...

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

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.

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

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

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 ...

The Phase III DIAMOND trial met both its primary and secondary endpoints of reducing tics in both children and adult patients ...

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