FDA Related News

Human Drugs

Rare Disease Status Given to Duchenne Therapy

FDA grants Wave Life Sciences a rare pediatric disease designation for WVE-N531 and its use in treating boys with Duchenne muscular dystrophy.

Biologics

NexoBrid Gets Expanded Use for Pediatric Burns

FDA approves a Vericel supplemental BLA for NexoBrid (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness or full-th...

Stakeholders Comment on Advisory Committee Session

Two stakeholders respond to an FDA request for comments on the agencys recent listening session on advisory committees and their governing processes.

Marketing

FDA Pushed to Regulate Online Drug Promos

Gardner Law says prescription drug manufacturers and marketers need to be sure their social media promotions can withstand FDA scrutiny pushed by Cong...

Human Drugs

Accelerated Approval for Gileads Livdelzi

FDA gives accelerated approval to Gileads Livdelzi to treat some cases of primary biliary cholangitis.

Human Drugs

Verrica Positive Data from Skin Cancer Trial

After reporting preliminary positive results from a Phase 2 clinical trial studying VP-315 in basal cell carcinoma patients, Verrica Pharmaceuticals s...

Human Drugs

FDA Approves Incytes Niktimvo

FDA approves Incytes Niktimvo for some adult and pediatric host-versus-graft treatments.

Human Drugs

Workshop on Measuring Gonadal Toxicity

FDA and the American Society of Clinical Oncology announce a 10/1 joint workshop entitled Measuring Toxicity in Reproductive Organs During Oncology Dr...

Medical Devices

Big Healths SleepioRx Cleared for Sleep Help

FDA clears a Big Health 510(k) for its SleepioRx, a digital therapeutic intended for treating chronic insomnia/insomnia disorder as an adjunct to usua...