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Multiple Violations at Empower Pharma

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

Norwich Loses Generic Rifaximin Case

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

FDA Has No Plans to Pull Abortion Pill: Makary

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

Abbott Recalls HeartMate Power Units

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

Staff Cuts Lead to Drug Data Gaps: Sources

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Axios reports that key FDA databases that are relied on by healthcare professionals are not being fully updated due to staff short...

FDA OKs Akesos Nasopharyngeal Cancer Therapy

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FDA approves an Akeso Biopharma BLA for penpulimab-kcqx, indicated for adults with recurrent or metastatic non-keratinizing nasoph...

ASCO Reaches Out to FDA, NIH, CMS

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

Cobenfy Effective as Schizophrenia Adjunct: Trial

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

Update Drug Labels with Obesity Info: Pitts

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

Lilly Sues 4 More Weight-Loss Drug Compounders

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