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FDA Extends Review of Pfizer Growth Hormone

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FDA extends by three months the review of a Pfizer/Opko Health BLA for somatrogon, a once-weekly long-acting recombinant human gro...

Advisory Panel to Discuss Reata Pharma NDA

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Federal Register notice: FDA announces a 12/8 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Reata Pharmac...

CDC Backs Most of FDA EUA for Covid Booster

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A CDC advisory panel recommends most of FDAs just-amended emergency use authorization (EUA) for Pfizer-BioNTechs Covid-19 vaccine ...

FDA Revises Authorizations of Some Covid Tests

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FDA requires additional conditions of authorization for many molecular, antigen, and serology Covid tests to keep up with emerging...

Panel to Discuss 2 Accelerated Approval NDAs

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Federal Register notice: FDA announces a 12/2 Oncologic Drugs Advisory Committee meeting that will panel hear certain updates on N...

Cordis Recalls Angiographic Catheter

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Cordis recalls its Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands due to the potential for the bands to...

Suspend Vitamin B6 Sales: Emery Pharma Petition

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Emery Pharma asks FDA to recall and suspend sales of vitamin B6 and take other regulatory actions.

10 Observations in Greenpark FDA-483

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FDA releases an FDA-483 with 10 observations from an inspection at Prescription Labs Inc.

IntegraDose Compounding Recalls 11 Cefazolin Lots

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IntegraDose Compounding Services recalls nine lots of antibiotic cefazolin 2g in 20 mL syringes for injection and two lots of cefa...

Reverse CA Decision Punishing Scientific Speech: WLF

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Washington Legal Foundation says the California Court of Appeals should reverse a trial court decision imposing $344 million in ci...