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Abiomed Pump Controller Needs Update: FDA

[ Price : $8.95]

FDA issues an Early Alert for an Abiomed Automated Impella Controller issue that has resulted in three deaths.

Delayed Hereditary Angioedema Drug Wins Approval

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After delaying a review action last month, FDA now approves a KalVista Pharmaceuticals NDA for Ekterly (sebetralstat) for treating...

FDA Priority Review for Hunter Syndrome Therapy

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FDA accepts for priority review a Denali Therapeutics BLA for tividenofusp alfa for treating Hunter syndrome.

FDA Inspectors Say Conditions Still Hard

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A ProPublica investigative report says FDA inspectors continue to have issues arising from the dismissal of many of their support ...

Priority Review for Mercks Winrevair

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FDA accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.

Vaccine Regulation Now a Political Process: Gottlieb

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Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vac...

Sandoz Recalls 1 Cefazolin Lot

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FDA says Sandoz has recalled one lot of Cefazolin for injection following a customer complaint that vials of another drug were inc...

FDA Clears Philips SmartSpeed Precise Software

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FDA clears Philips SmartSpeed Precise AI-enhanced software for MRI systems.

Myelodysplastic Syndrome Drug Development Guide

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FDA publishes a draft guidance to assist sponsors in developing drugs to treat myelodysplastic syndromes.

Positive Phase 3 Results for Moderna Flu Vaccine

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Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved very positive results in a Phase 3 efficacy trial.