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Human Drugs

Zevra Selling Priority Voucher for $150 Million

Zevra Therapeutics agrees to sell its Rare Pediatric Disease Priority Review Voucher for $150 million.

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Medical Devices

ROi CPS Recalls Newborn Kits

ROi CPS recalls its newborn kits after receiving an Urgent Field Safety Notice for a kit component from supplier Mercury Medical.

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Human Drugs

Praxis to Finish Study Despite Data Miss

Praxis Precision Medicines says it will continue a clinical trial despite an interim analysis recommendation that a clinical trial evaluating ulixacal...

Medical Devices

Bill to Block LDT Regulation

Reps. Finstad and Crenshaw introduce legislation to stop FDA from regulating laboratory-developed tests.

Human Drugs

FDA Warns Indias Granules Generic Drug Company

An Indian news service says FDA has sent a Warning Letter to drug manufacturer Granules following a 2024 inspection at the firms facility in Gagillapu...

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Medical Devices

Ventec Recalls VOCSN Ventilators

Ventec Life Systems recalls its VOCSN Multi-Function Ventilators because the devices were serviced using incorrect parts which can lead to device shut...

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Human Drugs

Makary FDA Confirmation Hearing Set for 3/6

The Senate Health Education Labor & Pensions committee sets a 3/6 confirmation hearing to review the nomination of Johns Hopkins surgeon and public po...

Biologics

FDA Suddenly Cancels Crucial Flu Vaccine Meeting

In a move linked to HHS secretary Robert F. Kennedy Jr., FDA suddenly cancels a 3/13-planned Vaccines and Related Biological Products Advisory Committ...

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Human Drugs

Fast-Track for Adicet Systemic Sclerosis Drug

FDA grants fast-track designation for Adicet Bios ADT-001 to treat systemic sclerosis.

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Human Drugs

19-Page Exela Pharma Sciences FDA-483

FDA releases the 19-page form FDA-483 with 15 observations from an inspection at the Exela Pharma Sciences outsourcing facility in Lenoir, NC.