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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Federal Register notice: FDA makes available a draft guidance entitled Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-P...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Micronor Not Withdrawn Over Safety/Efficacy: FDA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Five drug companies recommend changes to an FDA draft guidance on developing drugs to treat ulcerative colitis.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.

Fit-For-Purpose Clinical Outcome Assessment Guidance

FDA publishes a draft guidance to help sponsors develop fit-for-purpose clinical outcome assessment measures of patients health that are appropriate t...

Federal Register

FDA Determines Regulatory Review Period for Rukobia

Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for ViiV Healthcares Rukobia (fostemsavir trometh...

Federal Register

Regulatory Review Period for Danyelza

Federal Register notice: FDA determines for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics Danyelza (naxitamab-...