Sanofi says enrollment in a Phase 3 tolebrutinib trial has been paused due to an FDA partial clinical hold.
Federal Register notice: FDA determines that Janssen Pharmaceuticals Micronor (norethindrone tablets), indicated for preventing pregnancy, was not wit...
Five drug companies recommend changes to an FDA draft guidance on developing drugs to treat ulcerative colitis.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Horizon Therapeutics Tepezza (teprotumumab-trbw...
FDA grants breakthrough therapy designation to Janssens talquetamab for some multiple myeloma patients.
FDA publishes a draft guidance to help sponsors develop fit-for-purpose clinical outcome assessment measures of patients health that are appropriate t...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 notice: FDA determines for patent restoration purposes the regulatory review period for ViiV Healthcares Rukobia (fostemsavir trometh...
Federal Register notice: FDA determines for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics Danyelza (naxitamab-...