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Gilead Pays $202 Million Over Kickbacks Scheme

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Gilead Sciences agrees to pay $202 million to resolve claims that the company offered and paid kickbacks (e.g., honoraria payments...

Makary Suggests Raising Bar on Covid Boosters

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FDA commissioner Marty Makary suggests more data could be required for Covid-19 vaccine boosters this winter.

Little Trust in New Health Leaders: Poll

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A poll from the Harvard University T.H. Chan School of Public Health finds that more Americans say they will be trusting public he...

FDA Layoffs Affect Product Development: Post

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Skadden attorneys say the FDA reduction in force should have the greatest negative impact on products that are in development.

Cosco International CGMP Inspection Findings

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FDA warns Marietta, GA-based Cosco International about CGMP violations in its production of unapproved and misbranded drugs.

Bill Seeks to Kill Tax Deductions for DTC Ad Expenses

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A group of bipartisan House lawmakers introduce the No Handouts for Drug Advertisements Act, a bill that would prohibit tax deduct...

FDA Misses Review Decision on Stealth Bio NDA

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FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondri...

Amazon Selling Unapproved, Misbranded Drugs: FDA

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FDA warns Amazon it is marketing unapproved and misbranded external analgesic drug products for use before sensitive cosmetic proc...

CGMP Issues at BEO Pharmaceuticals

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FDA warns Brooksville, FL-based BEO Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.

Abeona Gains Approval of Resubmitted Zevaskyn

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FDA approves Abeona Therapeutics Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, an autologous cell-based gene t...