drug rejection – Talk Bio

Sarepta Therapeutics Faces FDA Crackdown after Third Patient Death; George Tidmarsh Named Top FDA Drug Regulator; Multiple Drugs Rejected; Pharma Invests Billions in US Manufacturing

3 days ago talkbio0Tagged drug rejection, ELEVIDYS, gene therapy, George Tidmarsh, Liver Failure, Acute, pharmaceutical manufacturing, reshoring, Study on Hold, United States Food and Drug Administration

Sarepta Therapeutics; FDA; gene therapy; Elevidys; acute liver failure; clinical hold; George Tidmarsh; drug rejection; reshoring; pharmaceutical manufacturing

Australia Rejects Eisai’s Alzheimer’s Drug Leqembi

5 months ago5 months ago talkbio0Tagged Alzheimer 's disease, Australia, drug rejection, Eisai, Leqembi, Transposition of Great Vessels

Leqembi, Eisai, Alzheimer’s disease, Australia, TGA, drug rejection

European Regulators Reject Eisai and Biogen’s Alzheimer’s Drug Leqembi

12 months ago talkbio0Tagged Agencies, Alzheimer 's disease, Biogen, drug rejection, Eisai, European (ethnic group), Leqembi

Eisai, Biogen, Leqembi, Alzheimer’s disease, European Medicines Agency, drug rejection