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FDA Wont Review Toriluzole NDA

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FDA says it wont review the BioHaven NDA for toriluzole to treat spinocerebellar ataxia because a Phase 3 trial did not meet its p...

RFK, Jr. for FDA or CDC: DeSantis

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Florida governor Ron DeSantis says that if he is elected president he might name avowed anti-vaxxer Robert F. Kennedy, Jr., to hea...

Drug Shortage Legislative Fix Introduced

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Sen. Gary Peters introduces bipartisan legislation he says will help ease drug shortages by requiring HHS to award contracts that ...

Abiomed Impella Pump Recall

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Abiomed recalls its Impella Left Sided Blood Pumps because the devices Instructions for Use do not adequately address precautions ...

Merck Pneumococcal Vaccine Hits Phase 3 Marks

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Merck says its investigational V116 21-valent pneumococcal conjugate vaccine hit key immunogenicity and safety endpoints in two Ph...

House Delays FDA Budget Floor Vote

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House GOP leadership delay a floor vote on FDAs fiscal year 2024 budget bill until lawmakers return from their August recess.

Panel to Review BrainStorm ALS Submission

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Federal Register notice: FDA announces a 9/27 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to discuss a BrainSt...

FDA Debars Daffin Over Covid Treatments

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Federal Register notice: FDA permanently debars Diana Daffin from providing services in any capacity to a person that has an appro...

Integrating ORA in Centers Has Risks: Analysis

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Attorney Tim Philips outlines best- and worst-case scenarios in the coming ORA reorganization.

Recall Unapproved Phenobarb Products: Sun

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Sun Pharma asks FDA to seek recalls of unapproved phenobarbitol products and notify healthcare providers and consumers of the dang...