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FDA OKs Leucovorin for Ultra-Rare Brain Disorder, But Not Autism

[ Price : $8.95]

FDA approves an expanded use of GSKs Wellcovorin (leucovorin calcium) tablets for treating cerebral folate deficiency in adult and...

CGMP Issues at Simtra BioPharma Solutions

[ Price : $8.95]

FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufacturing of finished drugs.

Novo Nordisk PADE Reporting Violations

[ Price : $8.95]

FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.

CGMP Violations at Fareva Morton Grove

[ Price : $8.95]

FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility...

FDA Issues Early Alert on Erbe Flexible Cryoprobes

[ Price : $8.95]

FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that som...

Hims & Hers Super Bowl Ad Hit

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The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement act...

FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

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Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are li...

Updated Guidance Clarifies Biosimilar Development Requirements

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FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.

Incyte Gets Complete Response Over Catalent Inspection Issues

[ Price : $8.95]

FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspectio...

Group urges Pfizer to Retract Threat on Drug Supplies

[ Price : $8.95]

Consumer advocacy group Public Citizen urges Pfizer to commit to maintaining access to its medicines in Europe after comments by C...