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Attorney Warns: FDA Watching Professional Promotion

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Attorney Nathan Downing says medical product companies should review their professional promotions as strictly as they review dire...

Patritumab BLA Pulled by Merck/Daiichi

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Merck and Daiichi Sankyo say they have withdrawn their BLA for the lung cancer drug patritumab deruxtecan.

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FDA publishes a draft guidance with recommendations for replacing color additives in approved or marketed drug products.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

Promising Trial Results for Wegovy Add-on: Veru

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Veru announces positive topline results from its Phase 2b QUALITY clinical trial that is evaluating enobosarm when added to semagl...