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FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.[ Price : $8.95]
FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch unifo...[ Price : $8.95]
Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diff...[ Price : $8.95]
FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.[ Price : $8.95]
FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.[ Price : $8.95]
FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.[ Price : $8.95]
FDA warns Indias Bhargava Phytolab about CGMP issues in its manufacturing of finished drugs and active pharmaceutical ingredients....[ Price : $8.95]
FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to ...