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FDA Marks 50th Anniversary of Device Amendments

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FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the laws lasting role in shaping the modern o...

FDA Updates Phillips Trilogy Ventilator Corrections

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FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that ...

Berens Infantile Niemann-Pick disease Drug Review Extended

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FDA extends by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-P...

Imfinzi Get Expanded Use in High-Risk Bladder Cancer

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FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-nav...

Pitts Named to BrainStorm Cell Therapeutics Board

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BrainStorm Cell Therapeutics names former FDA associate commissioner Peter Pitts to its board of directors.

Panel Recommends Dominant Covid Variant for Upcoming Vaccines

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An FDA advisory committee recommends updating Covid-19 vaccines for the 2026-2027 immunization season to target the currently domi...

Objectionable Conditions in Dr. Adnan Dahdul's Clinical Trial

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FDA warns Springfield, MA-based physician Adnan Dahdul about Bioresearch Monitoring violations in his conduct of a clinical invest...

Info Request Period on AI Use in Early Trials Extended

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FDA extends by 30 days the comment period on a request for information entitled AI-Enabled Optimization of Early-Phase Clinical Tr...

Lilly Loading Up Vaccines Plate for Former CBER Head Marks

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Eli Lilly says it is acquiring three vaccine developers in deals worth up to $3.8 billion combined, expanding its push into infect...

India OTC Drug Manufacturer Slapped With Form-483

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FDA cites Dabur India Limited for significant manufacturing and data integrity violations at an over-the-counter drug manufacturin...