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Woodcock Detailed to Commissioners Office

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CDER director Janet Woodcock accepts a detail in the Office of the Commissioner to start-up the Trump Administrations therapeutics...

CBER HCT/P Inspection Data Published

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CBER says the number of HCT/P inspections was down in FY 2019.

FDA Approves Dupixent for Pediatric Atopic Dermatitis

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FDA approves a Sanofi BLA for Dupixent (dupilumab) for children aged six to 11 years with moderate-to-severe atopic dermatitis who...

Cell2in Asks FDA OK for Glutathione Monitoring for BLAs

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Cell2in asks FDA to update guidances to identify real-time glutathione monitoring as an acceptable measure of potency for use in s...

Covid Drug Compounding Guidances Updated

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FDA announces updates to two guidances addressing drug compounding during the Covid-19 public health emergency.

New Medication Guides for Forms of 10 Drugs

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FDA releases a list of 10 drugs for which new medication guides are available.

3D Printed Swab Town Hall

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A CDRH virtual town hall focused on a collaboration between FDA, the VA, and the NIH to develop 3D printing of nasal swabs to ease...

Hikma Pharma Gains OK for Generic Vascepa

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Hikma Pharmaceuticals gains approval from FDA for its icosapent ethyl capsules, 1 gm, the generic equivalent of Amarin Pharmaceuti...

FDA Approves Kynmobi for Parkinsons Off Time

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FDA approves Sunovions Kynmobi for Parkinsons disease off-time use.

Takeda Gets Expanded OK for Alunbrig

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FDA approves a Takeda Pharmaceutical Company NDA for Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-posi...