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Human Drugs

Patritumab BLA Pulled by Merck/Daiichi

Merck and Daiichi Sankyo say they have withdrawn their BLA for the lung cancer drug patritumab deruxtecan.

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Biologics

Congressmen Hit FDA Covid Vaccine Limit

Eight congressional Democrats call on FDA to eliminate its new limits on Covid-19 vaccines.

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Human Drugs

Drug Product Color Additive Replacement Guide

FDA publishes a draft guidance with recommendations for replacing color additives in approved or marketed drug products.

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Human Drugs

Experimental Pancreatic Cancer Drug Gets Fast Track

FDA grants the Experimental Drug Development Center a fast-track designation for EBC-129 and its use for treating pancreatic ductal adenocarcinoma.

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Human Drugs

Beam Gets Orphan Status for Genetic Disorder

FDA grants Beam Therapeutics an orphan drug designation for BEAM-302, a liver-targeting lipid-nanoparticle that is designed to correct the disease-cau...

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Human Drugs

FDA Proposes Accelerated Approval Pathway for Stealth NDA

FDA issues Stealth BioTherapeutics a complete response letter that proposes the company resubmit its elamipretide NDA to seek accelerated approval for...

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Human Drugs

Alcon Dry Eye Drug Tryptyr Approved

FDA approves an Alcon NDA for Tryptyr (acoltremon ophthalmic solution) 0.003% for treating the signs and symptoms of dry eye disease.

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Human Drugs

Former McKinsey Partner Sentenced for Purdue Work

Former McKinsey & Company senior partner Martin Elling is sentenced to six months in federal prison, supervised release after incarceration, community...

Medical Devices

Multiple Issues at Germanys DRG Instruments

FDA warns Marburg, Germany-based DRG Instruments that it is marketing diagnostic devices that do not have FDA approval and are being manufactured with...

FDA General

House Democrats Want Answers on HHS Staff Cuts

Complaining about a lack of information from the department, top Democrats on the House Energy and Commerce Committee ask HHS Secretary Robert F. Kenn...