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United Health Products PMA for HemoStyp

[ Price : $8.95]

United Health Products files a PMA for HemoStyp, an absorbable hemostatic dressing for use in abdominal, cardiovascular, thoracic ...

Breakthrough Status for Janssens Niraparib

[ Price : $8.95]

FDA grants Janssen Pharmaceutical a breakthrough therapy designation for niraparib, an orally-administered poly ADP-ribose polymer...

Public Citizen Challenges Notion of Drug Prices Falling

[ Price : $8.95]

Public Citizen challenges President Trumps assertion that his actions are responsible for lower drug prices.

Guide on Enzyme Replacement Therapy Products

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Investigational Enzyme Replacement Therapy Products: Noncli...

Taxpayer Group Calls for More Relaxed FDA

[ Price : $8.95]

The Taxpayers Protection Alliance calls on FDA to make changes in its regulation of drugs, tobacco, and foods to promote innovatio...

Bioanalytical Methods Template Available

[ Price : $8.95]

FDA announces availability of a technical specifications guidance with bioanalytical methods templates.

FDA OKs Gileads Descovy for HIV Prevention

[ Price : $8.95]

FDA approves Gilead Sciences Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for use in certain at-risk adults and ...

Nippon Shinyaku Completes Rolling NDA for Duchenne Drug

[ Price : $8.95]

Nippon Shinyaku completes submission of a rolling NDA for viltolarsen, a Duchenne muscular disease drug that is amenable to exon 5...

Biofourmis AI Physiological Monitor Cleared

[ Price : $8.95]

FDA clears a Biofourmis 510(k) for its machine-learning and artificial intelligence-powered Biovitals Analytics Engine as a medica...

Fed Reg Notice on Pemoline Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 6/4 Federal Register notice withdrawing approval of five ANDAs for pemoline products becau...