FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
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...

latest-news-card-1
Human Drugs

Accelerated Approval for Gileads Livdelzi

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

latest-news-card-1
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...

latest-news-card-1
Human Drugs

FDA Approves Incytes Niktimvo

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

latest-news-card-1
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...

latest-news-card-1
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...

latest-news-card-1
Federal Register

Comments Sought on Scheduling for 8 Drugs

Federal Register notice: FDA seeks comments on the abuse potential, medical usefulness, trafficking, and impact of scheduling changes for eight drug s...

latest-news-card-1
Federal Register

Science Board Meeting on Alternative Methods

Federal Register notice: FDA announces a 10/7 Science Board Advisory Committee meeting that will hear an update from the new Alternative Methods Subco...

latest-news-card-1
Human Drugs

Changes Sought in REMS Logic Guidance

Two stakeholders call on FDA to make major changes to a draft guidance on the REMS logic model that is intended to link program design with assessment...