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Biologics

Lilly Loading Up Vaccines Plate for Former CBER Head Marks

Eli Lilly says it is acquiring three vaccine developers in deals worth up to $3.8 billion combined, expanding its push into infectious disease prevent...

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Human Drugs

India OTC Drug Manufacturer Slapped With Form-483

FDA cites Dabur India Limited for significant manufacturing and data integrity violations at an over-the-counter drug manufacturing facility in India.

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Medical Devices

Low PCCP Use Could be Missed Opportunity: Study

Researchers say manufacturers could make better use of predetermined change control plans for AI-enabled medical devices.

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Medical Devices

FDA, Federal Prosecutors Take Tougher Stance on Safety Reporting: Analysis

A Cooley legal analysis notes that FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulator...

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Human Drugs

CGMP Violations in GC America Inspection

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

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Human Drugs

AstraZeneca Breast Cancer NDA Review Extended by FDA

FDA extends its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional data tied to a close...

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Human Drugs

Corcept Plans Resubmission of Cushings NDA

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

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Human Drugs

AbbVies NDA for Dendritic Cell Neoplasms Approved

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

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Human Drugs

FDA-483 Response Can Influence Future Agency Action: Post

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

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Human Drugs

Alchymars ICM SM Inspection Issues

FDA warns Indias Alchymars ICM SM Private Limited about CGMP deviations in its production of active pharmaceutical ingredients.