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FDA commissioner Martin Makary pens an online JAMA Viewpoint to explain why the agency is moving to rein in direct-to-consumer pha...[ Price : $8.95]
CBER hosts a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes.[ Price : $8.95]
FDA under President Donald Trump advances plans discussed during the Biden Administration to scale back its long-standing practice...[ Price : $8.95]
Intercept Pharmaceuticals withdraws Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis, foll...[ Price : $8.95]
A USC Schaeffer Center for Health Policy and Economics white paper urges FDA to take several steps it says can modernize drug deve...[ Price : $8.95]
The Securities and Exchange Commission agrees to accept a FibroGen payment of $1.25 million to resolve a case involving tampering ...[ Price : $8.95]
A Clinical Trials Transformation Initiative meeting summary highlights four key issues discussed at its session on the state of cl...[ Price : $8.95]
FDA schedules an 11/6 Digital Health Advisory Committee meeting to examine the rise of generative artificial intelligence in digit...