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Human Drugs

Gilead Pays $202 Million Over Kickbacks Scheme

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

Biologics

Makary Suggests Raising Bar on Covid Boosters

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

FDA General

Little Trust in New Health Leaders: Poll

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

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FDA General

FDA Layoffs Affect Product Development: Post

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

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Human Drugs

Cosco International CGMP Inspection Findings

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

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Marketing

Bill Seeks to Kill Tax Deductions for DTC Ad Expenses

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

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Human Drugs

FDA Misses Review Decision on Stealth Bio NDA

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

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Human Drugs

Amazon Selling Unapproved, Misbranded Drugs: FDA

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

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Human Drugs

CGMP Issues at BEO Pharmaceuticals

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

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Biologics

Abeona Gains Approval of Resubmitted Zevaskyn

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