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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...

Low PCCP Use Could be Missed Opportunity: Study

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Researchers say manufacturers could make better use of predetermined change control plans for AI-enabled medical devices.

FDA, Federal Prosecutors Take Tougher Stance on Safety Reporting: Analysis

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A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety...

CGMP Violations in GC America Inspection

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FDA warns Alsip, IL-based GC America about CGMP violations in its production of finished drugs.

AstraZeneca Breast Cancer NDA Review Extended by FDA

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FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional ...