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Pfizer submits an NDA to FDA for Paxlovid to treat Covid-19 patients at high risk for progression to serious illness.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Patient-Focused Drug Development: Selecting, Developing, or...[ Price : $8.95]
Sanofi says enrollment in a Phase 3 tolebrutinib trial has been paused due to an FDA partial clinical hold.[ Price : $8.95]
Federal Register notice: FDA determines that Janssen Pharmaceuticals Micronor (norethindrone tablets), indicated for preventing pr...[ Price : $8.95]
Five drug companies recommend changes to an FDA draft guidance on developing drugs to treat ulcerative colitis.[ Price : $8.95]
FDA tells Covid-19 vaccine manufacturers seeking to update their vaccines that they should develop modified vaccines that add an o...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Horizon Therapeutics Tepezz...[ Price : $8.95]
FDA extends by three months the review of a Provention Bio BLA for teplizumab, indicated for delaying progression to Stage 3 clini...