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, ...

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 ...

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

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

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 ...

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

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 ...