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Human Drugs

Apellis NDA for Geographic Atrophy Drug

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

Human Drugs

Add Dementia Boxed Warning to PPI Labeling: Petition

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

Medical Devices

FDA Updates Device Covid FAQ

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

Medical Devices

FDA De Novo Marketing for 4 Weight-Loss Devices

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

Biologics

CDC Recommends Use of Novavax Covid Vaccine

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

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Medical Devices

CDRH Seeks Feedback on eSubmission Process

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

Federal Register

Draft Guide on Vet Drug Residual Solvents

Federal Register notice: FDA makes available a draft guidance #100 entitled Impurities: Residual Solvents in New Veterinary Medicinal Products, Active...

Human Drugs

Sanofi Scraps Phase 2 Study of Lademirsen

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

Human Drugs

Acer Refiles NDA for Urea Disorder Drug

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

Federal Register

New CDISC Versions Support and Use Dates Announced

Federal Register notice: FDA announces the date that support begins for versions 1.2 and 1.3 of the Clinical Data Interchange Standards Consortiums An...