FDA warns Indias Macsen Drugs about CGMP deviations in its production of active pharmaceutical ingredients.
Johnson & Johnson files a supplemental BLA seeking to update the prescribing information for Tremfya (guselkumab) to include new data demonstrating it...
FDA recommends placing 7-hydroxymitragynine (7-OH) a highly concentrated, synthetic byproduct of the kratom plant under the Controlled Substances Act...
FDA warns Indias Shiva Analyticals Private Limited about CGMP violations in its work as a contract testing laboratory.
The CDER Office of Pharmaceutical Quality publishes a white paper making the economic case for quality management practices.
FDA issues a question-and-answer guidance on the development of certain antibacterial therapies.
FDA approves a PTC Therapeutics NDA for Sephience (sepiapterin), indicated for treating adult and pediatric patients with phenylketonuria, a rare inhe...
FDA posts the user fee rates for fiscal year 2026 for prescription drugs and biologics, biosimilar, medical devices and generic drugs.
