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RFK Jr. Restoring FDAs Freedom of Information Office

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

Breakthrough Status for Blood Pressure Therapy

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FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation therapy that uses a pac...

Texas Court Gives FDA Win in Compounding Enforcement

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A Northern Texas federal judge denies a preliminary injunction sought by Outsourcing Facilities Association to delay FDA enforceme...

An FDA Reviewer Exodus on the Horizon: Gottlieb

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Former FDA commissioner Scott Gottlieb says FDA is likely to see up to a 25% reviewer exodus over the coming months as about 600 r...

One-Third of Biosimilars Approved Not Launched: Report

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A new biosimilars report says that FDA has approved a total of 73 biosimilars across 19 unique biological molecules, and so far on...

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...

BrainChild Breakthrough Status for Brain Tumor Therapy

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

Amneal Recalls Ropivacaine Hydrochloride Injection

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Amneal Pharmaceutical recalls two lots of ropivacaine hydrochloride injection USP, 500 mg/100 mL, infusion bags because the produc...

FDA Alert on False Positive Lead Tests

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