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FDA Oks Sanofis Hemophilia A Drug

[ Price : $8.95]

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

Ivermectin Not Effective in Treating Covid: Study

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A JAMA study that looked at ivermectin as a therapy for treating adult outpatients with mild to moderate Covid-19 finds that the d...

FDA Updates Examples of Medical Device Misconnections

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

FDA Exploring New Device Active Surveillance System

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

FDA Evaluating Neonatal Incubator Airborne Chemicals

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

USPTO Should Check Keytruda Patent Requests: Lawmakers

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

Amneal Pharmaceuticals FDA-483 Released

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

Lessons Learned from Covid Vaccine Development

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

Asacol Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Allergans Asacol HD (mesalamine) delayed-release tablet, 800 mg, was not withdrawn du...

Topamax Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determined that Janssens Topamax (topiramate) sprinkle capsules, 50 mg, was not withdrawn due to safe...