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FDA General

RFK Jr. Restoring FDAs Freedom of Information Office

HHS secretary Robert F. Kennedy Jr. vows to restore FDAs and other health agencies Freedom of Information Act (FOIA) offices that were gutted earlier ...

Medical Devices

Breakthrough Status for Blood Pressure Therapy

FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation therapy that uses a pacemaker to reduce blo...

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Human Drugs

Texas Court Gives FDA Win in Compounding Enforcement

A Northern Texas federal judge denies a preliminary injunction sought by Outsourcing Facilities Association to delay FDA enforcement actions against c...

Human Drugs

BrainChild Breakthrough Status for Brain Tumor Therapy

FDA awards BrainChild Bio a breakthrough therapy designation for its investigational CAR T-cell therapy, BCB-276, for treating a rare and fatal pediat...

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Human Drugs

Amneal Recalls Ropivacaine Hydrochloride Injection

Amneal Pharmaceutical recalls two lots of ropivacaine hydrochloride injection USP, 500 mg/100 mL, infusion bags because the products may contain an in...

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Human Drugs

FDA Alert on False Positive Lead Tests

FDA alerts health care providers about reports of falsely elevated results associated with ASP Globals RAM Scientific SAFE-T-FILL Micro Capillary Bloo...

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Human Drugs

Multiple Violations at Empower Pharma

FDA warns Houston, TX-based Empower Pharma about multiple violations in its production of unapproved and misbranded compounded drugs.

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Human Drugs

Norwich Loses Generic Rifaximin Case

The DC federal court throws out Norwichs suit seeking to force FDA to find that Actavis has forfeited its exclusivity for a generic form of rifaximin ...

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Human Drugs

FDA Has No Plans to Pull Abortion Pill: Makary

FDA commissioner Martin Makary says there are no current plans to restrict access to the abortion drug mifepristone.

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Medical Devices

Abbott Recalls HeartMate Power Units

Abbott recalls its HeartMate Mobile Power Unit to remove the component due to instances where the device experiences a sudden power loss.