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Priority Review for Mercks Winrevair

[ Price : $8.95]

FDA accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.

Vaccine Regulation Now a Political Process: Gottlieb

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Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vac...

Sandoz Recalls 1 Cefazolin Lot

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FDA says Sandoz has recalled one lot of Cefazolin for injection following a customer complaint that vials of another drug were inc...

FDA Clears Philips SmartSpeed Precise Software

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FDA clears Philips SmartSpeed Precise AI-enhanced software for MRI systems.

Myelodysplastic Syndrome Drug Development Guide

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FDA publishes a draft guidance to assist sponsors in developing drugs to treat myelodysplastic syndromes.

Positive Phase 3 Results for Moderna Flu Vaccine

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Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved very positive results in a Phase 3 efficacy trial.

Bioresearch Monitoring Violations by Dr. Peter Michael

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FDA warns Hialeah, FL-based physician Peter Michael about failing to follow the investigation plan in two clinical studies.

Regenerons Lynozyfic Approved for Some Myelomas

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FDA gives accelerated approval to Regenerons Lynozyfic for some multiple myelomas.

Healwell Homeo Private Selling Adulterated Drugs: FDA

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FDA warns Indias Healwell Homeo Private Limited about producing adulterated homeopathic and OTC drugs with CGMP violations.

Contec and Epsimed Cybersecurity Patch

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FDA says Contec has issued a software patch that resolves cybersecurity vulnerabilities in certain Contec and Epsimed patient moni...