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FDA publishes the International Council for Harmonization M14 guidance on planning, designing, analyzing, and reporting non-interv...[ Price : $8.95]
FDA publishes the International Council for Harmonization E2D(R1) guidance on management and reporting of postapproval individual ...[ Price : $8.95]
FDA posts the form FDA-483 issued following a 2024 inspection at Japans Fukuzyu Pharmaceutical Co.[ Price : $8.95]
FDA cites a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic (semaglutide), calling the ad ...[ Price : $8.95]
FDA posts a complete-response letter that outlined last month's rejection of Regenxbios BLA for its gene therapy clemidsogene lanp...[ Price : $8.95]
Politico reports that HHS secretary Robert F. Kennedy Jr. said FDA will soon approve a way to make some peptides more accessible t...[ Price : $8.95]
FDA recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its ...[ Price : $8.95]
Merck says that adding Welireg (belzutifan) to Keytruda as adjuvant therapy significantly reduced the risk of disease recurrence o...