FDA Related News

Human Drugs

FDA Approves Fresenius Kabi Biosimilar

FDA approves Fresenius Kabis Stimufend biosimilar for Amgens Neulasta.

Human Drugs

FDA Lifts Hold on Sarepta Duchenne Drug Trial

FDA lifts its clinical hold on Sareptas investigational Duchenne muscular dystrophy drug SRP-5051.

Human Drugs

Leaf of Life Marketing Illegal New Drugs: FDA

FDA warns St. Louis, MO-based Leaf of Life that its Web site takes orders for dietary supplements that are legally considered to be misbranded unappro...

Medical Devices

Boston Scientifics Watchman Gets Revised Label

FDA approves expanded labeling for Boston Scientifics Watchman FLX Left Atrial Appendage Closure Device to include a 45-day dual anti-platelet therapy...

Human Drugs

CDER Working to Optimize Drug Absorption

CDER scientists are working to improve the bioavailability of generic drugs that do not dissolve well in water.

Federal Register

Marinus Pharma Wins Priority Review Voucher

Federal Register notice: FDA issues a priority review voucher to Marinus Pharmaceuticals for gaining approval of a rare pediatric disease product appl...

Federal Register

Notice on Makena Hearing Corrected

Federal Register notice: FDA corrects an 8/17 notice on a 10/17-19 hearing request to review and vote on whether agency approval for Covis Makena (hyd...

Biologics

Alvotech Inspection Findings Hold Up Humira Biosimilar

FDA sends Alvotech a complete response letter on its proposed Humira biosimilar AVT02, citing inspection deficiencies at its Reykjavik, Iceland manufa...

Human Drugs

FDA Denies Most of Salix Xifaxin Petition

FDA denies most requests in a Salix Pharmaceuticals petition asking for restrictions on approval of ANDAs citing its Xifaxin as the reference-listed d...

Bayer Paying $40 Million to Settle 2 Whistleblower Suits

Bayer agrees to pay $40 million to the federal government and 20 states to resolve two whistleblower False Claims Act suits over three of its drugs.