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Human Drugs

Staff Cuts Lead to Drug Data Gaps: Sources

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

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Human Drugs

FDA OKs Akesos Nasopharyngeal Cancer Therapy

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

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.

Biologics

FDA Seeks Post-Marketing Commitment from Novavax

Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.