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Respironics Recalls DreamStation Ventilators

[ Price : $8.95]

Philips Respironics recalls (Class 1) certain DreamStation auto continuous positive airway pressure and auto bilevel positive airw...

Makary JAMA Piece Explains DTC Ad Crackdown

[ Price : $8.95]

FDA commissioner Martin Makary pens an online JAMA Viewpoint to explain why the agency is moving to rein in direct-to-consumer pha...

Intercept Withdraws Ocaliva Amid Liver Safety Concerns

[ Price : $8.95]

Intercept Pharmaceuticals withdraws Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis, foll...

Ways FDA Can Modernize Drug Development

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A USC Schaeffer Center for Health Policy and Economics white paper urges FDA to take several steps it says can modernize drug deve...

FibroGen Paying $1.25 Million to SEC

[ Price : $8.95]

The Securities and Exchange Commission agrees to accept a FibroGen payment of $1.25 million to resolve a case involving tampering ...

State of Clinical Trials CTTI Meeting Summary

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A Clinical Trials Transformation Initiative meeting summary highlights four key issues discussed at its session on the state of cl...

FDA to Scrutinize AI-Powered Mental Health Devices

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FDA schedules an 11/6 Digital Health Advisory Committee meeting to examine the rise of generative artificial intelligence in digit...

Capsida Pauses Gene Therapy Trial After Death

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Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 ...

Prasad Reassumes Chief Medical/Scientific Officer Role

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FDA commissioner Marty Makary reinstates CBER director Vinay Prasads previous additional duties as the agencys chief medical and s...

Expanded Approval for AZs Koselugo

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FDA approves an expanded indication to include pediatric patients aged one and older for AstraZenecas Koselugo to treat some cases...