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Imfinzi Get Expanded Use in High-Risk Bladder Cancer

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FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-nav...

Pitts Named to BrainStorm Cell Therapeutics Board

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BrainStorm Cell Therapeutics names former FDA associate commissioner Peter Pitts to its board of directors.

Panel Recommends Dominant Covid Variant for Upcoming Vaccines

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An FDA advisory committee recommends updating Covid-19 vaccines for the 2026-2027 immunization season to target the currently domi...

CGMP Violations in GC America Inspection

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FDA warns Alsip, IL-based GC America about CGMP violations in its production of finished drugs.

AstraZeneca Breast Cancer NDA Review Extended by FDA

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FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional ...

Corcept Plans Resubmission of Cushings NDA

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Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushings syndrome, following addi...

AbbVies NDA for Dendritic Cell Neoplasms Approved

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FDA approves an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy) and its use in treating adults with blastic plasmacytoid dendrit...

FDA-483 Response Can Influence Future Agency Action: Post

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NSF consultants report on a webinar discussing the best practices in responding to inspection observations in a form FDA-483.

Objectionable Conditions in Dr. Adnan Dahdul's Clinical Trial

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FDA warns Springfield, MA-based physician Adnan Dahdul about Bioresearch Monitoring violations in his conduct of a clinical invest...

Info Request Period on AI Use in Early Trials Extended

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FDA extends by 30 days the comment period on a request for information entitled AI-Enabled Optimization of Early-Phase Clinical Tr...