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Human Drugs

CMS Continues Block on Alzheimers Drug Coverage

The Centers for Medicare & Medicaid Services says it is not reconsidering its national coverage determination that restricts Medicare coverage on Alzh...

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Human Drugs

FDA Urged to Pull Failed Cancer Drugs Faster

University of Pennsylvania researchers call on FDA to act more quickly when accelerated approval cancer drugs fail confirmatory tests to cut the time ...

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Biologics

FDA Oks Sanofis Hemophilia A Drug

FDA approves a BLA from Sanofis Bioverativ Therapeutics unit for Altuviiio (efanesoctocog alfa), a recombinant DNA-derived, factor VIII concentrate in...

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Human Drugs

Ivermectin Not Effective in Treating Covid: Study

A JAMA study that looked at ivermectin as a therapy for treating adult outpatients with mild to moderate Covid-19 finds that the drug does not reduce ...

Medical Devices

FDA Updates Examples of Medical Device Misconnections

FDA adds a new case study to its Examples of Medical Device Misconnections Web page.

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Medical Devices

FDA Exploring New Device Active Surveillance System

FDA posts a sources sought information request that seeks potential contractors who may be able to develop and implement a medical device active surve...

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Medical Devices

FDA Evaluating Neonatal Incubator Airborne Chemicals

FDA says it is evaluating reports of exposure to airborne chemicals that may be associated with the use of neonatal incubators.

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Human Drugs

USPTO Should Check Keytruda Patent Requests: Lawmakers

Four Democrat senators and representatives say the U.S. Patent and Trademark Office should weigh a new Merck patent request for a subcutaneous formula...

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Human Drugs

Amneal Pharmaceuticals FDA-483 Released

FDA releases the form FDA-483 issued following an inspection at the Ahmedabad, India-based Amneal Pharmaceuticals Private Limited parenteral manufactu...

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Biologics

Lessons Learned from Covid Vaccine Development

CBER director Peter Marks discusses four lessons learned from the rapid development of Covid-19 vaccines and the implications for the future.