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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.

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ASCO Reaches Out to FDA, NIH, CMS

The Association for Clinical Oncology tells the new leaders of FDA, NIH, and CMS it looks forward to working with them on behalf of cancer research an...

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Human Drugs

Cobenfy Effective as Schizophrenia Adjunct: Trial

Bristol Myers Squib says its Cobenfy showed positive results in the Phase 3 ARISE trial as an adjunctive therapy to atypical antipsychotics for patien...

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Human Drugs

Update Drug Labels with Obesity Info: Pitts

Former FDA associate commissioner Peter Pitts calls on the agency to revise drug labels with obesity safety and effectiveness information.

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Human Drugs

Lilly Sues 4 More Weight-Loss Drug Compounders

Lilly sues four additional drug compounders for illegally selling copies of its weight loss and diabetes drugs.