FDA warns Chinas Jinan Jinda Pharmaceutical Chemistry Co. about CGMP deviations in its production of active pharmaceutical ingredients.
FDA says it concurs with the World Health Organization that breast implant-associated anaplastic large cell lymphoma is a rare T-cell lymphoma that ca...
FDA approves a Newron Pharmaceuticals NDA for Xadago (safinamide) tablets as an add-on treatment for patients with Parkinsons disease who are currentl...
Law professor Robert Bohrer makes the case for a conditional drug approval process that would bring drugs to patients faster and at a discounted price...
FDA grants NantKwest an orphan drug designation for the companys activated natural killer cell therapy for treating patients with advanced Merkel cell...
FDA releases its latest batch of Warning Letters that cite ARK Bio-Medical, Jinan Jinda Pharmaceutical, and USV Private Limited.
FDA denies a ProbioTech petition asking it to take steps to amend the dietary supplement definition so that a probiotic suppository could be considere...
Former FDA commissioner Robert Califf says transformational progress of the clinical trials enterprise is in sight and will be aided by more education...