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Sangamo Begins Rolling BLA for Fabry Gene Therapy

[ Price : $8.95]

Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, ...

Bayers Asundexian Cuts Recurrent Stroke Risk in Phase 3

[ Price : $8.95]

Bayer reports that its investigational oral anticoagulant asundexian reduced the risk of recurrent ischemic stroke by 26% in patie...

Industry Explains PDUFA 8 Facility Lifecycle Counterproposal

[ Price : $8.95]

A PDUFA 8 negotiating subgroup reviews industrys counterproposal to FDAs facility lifecycle proposal.

Telehealth Firm Undercuts Novo GLP-1 Pill Price: Reuters

[ Price : $8.95]

Reuters reports exclusively that the telehealth firm Hims and Hers Health is selling GLP-1 pills for $100 less per month than the ...

J&Js Cerenovus Recalls Neurovascular Coil Devices

[ Price : $8.95]

Johnson & Johnson MedTech recalls multiple versions of its Cerepak Detachable Coil System, which are used to treat intracranial an...

U.S. Specialty Formulations FDA-483 Out

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FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility i...

FDA Updates Safety Labels for Chemo Drugs

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FDA updates the safety labeling for the widely used chemotherapy drugs capecitabine (Genentechs Xeloda) and fluorouracil (multiple...

Software Assurance Guidance Supplement

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FDA publishes a guidance with recommendations on computer software assurance for computers and automated data processing systems u...

QS Violations at Flextronics America

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FDA warns Austin, TX-based Flextronics America about Quality Systems violations in its manufacturing of a continuous glucose meter...

CGMP Violations Found in Cohance Lifesciences Inspection

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FDA warns Indias Cohance Lifesciences about CGMP violations in its production of drugs at one of its manufacturing sites.