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Bayer Looking to Expand Nubeqa Indication

[ Price : $8.95]

Bayer says it will present positive results from a Phase 3 Nubeqa prostate cancer trial to FDA to consider a potential indication ...

Priority Review for Atara Gene Therapy

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FDA accepts for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel, indicated as monotherapy for treating...

Almost 3,000 Establishment Inspections in FY 2023

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The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type an...

GMP Violations in YangZhou Records Review

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FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.

CGMP Violations at Jiangsu Hengrui

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FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs

Combination Product Application User Fees

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FDA publishes a guidance on how it calculates combination product application user fees.

FDA Accepts Lexicon NDA for Resubmitted Diabetes Drug

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FDA accepts for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy fo...

Guidance on Pediatric IBD Drug Development

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FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.

FDA Wants to Stem Common Chronic Diseases: Califf

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FDA commissioner Robert Califf says many stakeholders need to work together to improve interventions for common chronic diseases.

Smith+Nephew New Hip System Cleared

[ Price : $8.95]

FDA clears a Smith+Nephew 510(k) for its new Catalystem Primary Hip System.