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Medical Devices

Sentators Urge FDA to Allow OTC Hearing Aids

Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) urge FDA to finalize a proposed rule on making certain hearing aids available over the coun...

Biologics

FDA Review Extended on Provention Bio BLA

FDA extends by three months the review of a Provention Bio BLA for teplizumab, indicated for delaying progression to Stage 3 clinical Type 1 diabetes ...

Federal Register

Optical Melanoma Detection Device Reclassified

Federal Register notice: FDA proposes to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from Clas...

Human Drugs

Pfizer Submits Paxlovid NDA

Pfizer submits an NDA to FDA for Paxlovid to treat Covid-19 patients at high risk for progression to serious illness.

Federal Register

Draft Guide on Clinical Outcome Assessments

Federal Register notice: FDA makes available a draft guidance entitled Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-P...

Human Drugs

Partial Clinical Hold on Sanofi MS Drug Trial

Sanofi says enrollment in a Phase 3 tolebrutinib trial has been paused due to an FDA partial clinical hold.

Federal Register

Micronor Not Withdrawn Over Safety/Efficacy: FDA

Federal Register notice: FDA determines that Janssen Pharmaceuticals Micronor (norethindrone tablets), indicated for preventing pregnancy, was not wit...

Human Drugs

Stakeholders Suggest Changes to Ulcerative Colitis Drug Guidance

Five drug companies recommend changes to an FDA draft guidance on developing drugs to treat ulcerative colitis.

Federal Register

Regulatory Review Period for Horizons Tepezza

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Horizon Therapeutics Tepezza (teprotumumab-trbw...

Human Drugs

Breakthrough Designation for Janssens Talquetamab

FDA grants breakthrough therapy designation to Janssens talquetamab for some multiple myeloma patients.