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FDA Approves Humacytes Symvess

[ Price : $8.95]

FDA approves Humacytes Symvess for use with some extremity arterial injuries.

Guide on Drug Batch Uniformity and Integrity

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FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch unifo...

Chimerix NDA for Glioma Drug

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Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diff...

FDA Wants Labeling Changes for Buprenorphine

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FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to ...

Global Unique Device ID Database Guidance

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FDA publishes an updated Global Unique Device Identification Database guidance.

FDA Approves Novo Hemophilia Prophylaxis Drug

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FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.

New Sleep Apnea Indication for Lillys Zepbound

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FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.

Astellas Recalls Lots of Prograf and Astagraf

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FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.

Bhargava Phytolab CGMP Violations

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FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients....

QS, MDR Violations at Rontis Hellas in Greece

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FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon cathet...