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Congressmen Hit FDA Covid Vaccine Limit

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

Drug Product Color Additive Replacement Guide

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FDA publishes a draft guidance with recommendations for replacing color additives in approved or marketed drug products.

Experimental Pancreatic Cancer Drug Gets Fast Track

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

Beam Gets Orphan Status for Genetic Disorder

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

FDA Proposes Accelerated Approval Pathway for Stealth NDA

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

Alcon Dry Eye Drug Tryptyr Approved

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

Former McKinsey Partner Sentenced for Purdue Work

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

Multiple Issues at Germanys DRG Instruments

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

House Democrats Want Answers on HHS Staff Cuts

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

FDA Publishes 2 Q-Submission Guidances

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FDA publishes two guidances relating to the CDRH/CBER Q-submission process.