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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...[ Price : $8.95]
FDA accepts for priority review a Takeda and Protagonist Therapeutics NDA for rusfertide, positioning the drug as a potential firs...[ Price : $8.95]
Pfizer CEO Albert Bourla tells TD Cowen healthcare conference that the leadership of FDAs biologics center is worrisome because it...[ Price : $8.95]
FDA removes a clinical hold against Intellia Therapeutics and its MAGNITUDE Phase 3 trial of nexiguran ziclumeran (nex-z), an expe...[ Price : $8.95]
Three former senior FDA officials tell a federal appeals court that the Trump administration mischaracterized the science on contr...