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Human Drugs

Eisai/Biogen Alzheimers Drug Effective: FDA

FDA medical reviewers ask members of the Peripheral and Central Nervous System Drugs Advisory Committee to confirm the benefits and risks of Eisai/Bio...

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Human Drugs

PMI Major Change in Drug Labeling: Attorneys

Five Hogan Lovells attorneys explain how an FDA proposal to require Patient Medication Information would represent a significant change in drug labeli...

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Human Drugs

Bioresearch Monitoring Issues in Mazhar Trials

FDA warns Houston, TX-based physician Mobeen Mazhar about violations in conducting three clinical trials.

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Biologics

CBER Post-Covid Transition Information

CBER updates information for regulated entities on the return to normal operations with the end of the Covid-19 public health emergency.

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Medical Devices

AdvaMed Recommendations for Patient Preference

AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient preference information, and also recommends change...

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Human Drugs

FibroGens Pamrevlumab Fails Phase 3

FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dystrophy in a Phase 3 trial.

Human Drugs

FDAs Needs to Better Address Drug Shortages

FDA says that while drug shortages have declined since 2011, there still are needs to be addressed to help the agency prevent or mitigate shortages.

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Human Drugs

FDA OKs Mercks Prevymis for Kidney Transplants

FDA approves Mercks Prevymis (letermovir) for prophylaxis of cytomegalovirus disease in adult kidney transplant recipients.

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Biologics

Legend Bio sBLA to Expand Carvyktis Use

Legend Biotech files a supplemental BLA seeking to expand the label for Carvykti (ciltacabtagene autoleucel) to include the treatment of adult patient...

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Medical Devices

Teleflex Pacing Guidewire Cleared

FDA clears a Teleflex 510(k) for its Wattson Temporary Pacing Guidewire a bipolar temporary device designed specifically for use during transcatheter...