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Pazdur, Others Concerned About Voucher Program Integrity

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Former FDA oncology drug leader Richard Pazdur says concerns surrounding a controversial fast-track drug review initiative under c...

Alert Issued on Vantives Prismaflex Systems

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FDA alerts healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after...

Clinical Hold Lifted on GH Research Antidepressant

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FDA lifts a clinical hold against GH Researchs investigational antidepressant GH001, clearing the way for patient enrollment in th...

Novartis Wins Breakthrough Status for Ianalumab

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FDA grants Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogrens disease.

8 Observations in Shilpa Medicare 483

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FDA releases the form FDA-483 with eight observations from an inspection at Indias Shilpa Medicare drug manufacturing facility.

Chinese Firms Asked About Counterfeit GLP-1 Drugs

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The ranking member of a House Select Committee on competition with China writes to three Chinese drug companies asking for detaile...

Teclistamab Cuts Myeloma Risk of Progression by 71%: J&J

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Johnson & Johnson reports positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli ...

Scholar Rock Plans BLA Resubmission for Apitegromab

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Scholar Rock plans to resubmit its BLA seeking approval of apitegromab, a first-in-class muscle-targeted therapy for spinal muscul...

IND Review Procedures SOPP

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CBER publishes a Standard Operating Policy and Procedure on IND administrative processing and review management procedures.

Compounder Says Lilly, Novo Nordisk Violate Antitrust

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Strive Specialties, a compounding pharmacy, says in a suit filed in a Texas federal court that Eli Lilly and Novo Nordisk are viol...