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Roche Elecsys Amyloid Plasma Panel is Breakthrough Device

[ Price : $8.95]

FDA grants breakthrough device designation for the Roche Elecsys Amyloid Plasma Panel that detects and measures Alzheimers disease...

Apellis NDA for Geographic Atrophy Drug

[ Price : $8.95]

FDA accepts for priority review an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan, an investigational, targeted C3 the...

Add Dementia Boxed Warning to PPI Labeling: Petition

[ Price : $8.95]

The Alliance for Natural Health calls on FDA to require a Boxed Warning for proton pump inhibitors on the risk of dementia associa...

FDA Updates Device Covid FAQ

[ Price : $8.95]

FDA adds two updates to its Web page FAQs on Supplies of Medical Devices for Covid-19.

FDA De Novo Marketing for 4 Weight-Loss Devices

[ Price : $8.95]

FDA grants de novo marketing authorizations for Apollo Endosurgery and its Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REV...

CDC Recommends Use of Novavax Covid Vaccine

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The U.S. CDC Advisory Committee on Immunization Practices votes unanimously to recommend the use of the Novavax Covid-19 Vaccine, ...

CDRH Seeks Feedback on eSubmission Process

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CDRH seeks feedback on its new eSTAR and eCopy electronic submission process for 510(k) and De Novo device submissions.

Draft Guide on Vet Drug Residual Solvents

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Federal Register notice: FDA makes available a draft guidance #100 entitled Impurities: Residual Solvents in New Veterinary Medici...

Sanofi Scraps Phase 2 Study of Lademirsen

[ Price : $8.95]

Sanofi tells Regulus Therapeutics that it is terminating a Phase 2 clinical study (HERA Study) of lademirsen (RG-012) for treating...

Acer Refiles NDA for Urea Disorder Drug

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Acer Therapeutics resubmits its NDA for ACER-001 (sodium phenylbutyrate) for oral suspension for treating patients with urea cycle...