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Medical Devices

2 Medical Device FAQs Issued

FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse events.

Biologics

Celltrions Humira Biosimilar Now Interchangeable: FDA

FDA grants interchangeable biosimilar status to Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.

Human Drugs

Trump to FDA: Boost Generics, OTCs, Rx Imports

A presidential executive order tells FDA to suggest administrative and legislative ways to improve the availability of generic and OTC drugs and to ma...

Human Drugs

Petition Seeks GMP Amendment for Sampling Logbooks

A citizen petition urges FDA to amend the requirements under 21 CFR Part 211 (finished pharmaceuticals GMPs) to mandate the use of separate sampling l...

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Human Drugs

Naturista Store Markets Unapproved Drug: FDA

FDA warns Downey, CA-based Naturista Store that it is marketing an unapproved, misbranded drug as a dietary supplement that contains undeclared active...

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Human Drugs

CGMP Issues Found in PMS4PMS Inspection

FDA warns Clarence, NY-based PMS4PMS that it is illegally marketing a misbranded over-the-counter menstrual cream that is manufactured with CGMP viola...

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Human Drugs

FDA Clears eGenesis Perfusion Trial

FDA clears a Phase 1 human trial of an eGenesis porcine liver for use with an OrganOx system for perfusion of intensive care patients with acute-on-ch...

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Human Drugs

Amlitelimab Benefit in Inflammatory Asthma: Sanofi

Sanofi says data from a Phase 2 study of amlitelimab misses its endpoint in adults with moderate-to-severe asthma, while promising data were seen in h...

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Human Drugs

Mural Oncology Scraps Nemvaleukin Alfa

Mural Oncology discontinues all clinical development of its lead drug candidate, nemvaleukin alfa based on disappointing results from two key trials i...

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Medical Devices

FDA Authorizes Clicks Migraine Digital Therapeutic

FDA grants Click Therapeutics a de novo marketing authorization for its prescription digital therapeutic, CT-132, a prescription digital therapeutic f...