CBER director Vinay Prasad orchestrates leadership changes at the Center, appointing several new acting deputy directors and reassigning key staff.
The D.C. federal court says FDA correctly approved labeling for MSNs generic form of Novartis Entresto.
FDA warns Lutz, FL-based New Life Medical Services that it is illegally marketing unapproved human cells, tissues, and cellular and tissue-based produ...
Age Reversal Unity petitions FDA to create a new regulatory pathway to cover so-called enhanced drugs to fight aging as a disease.
Complement Therapeutics gains IND clearance to begin human testing of its lead gene therapy, CTx001, in patients with geographic atrophy secondary to ...
FDA grants Vivace Therapeutics a fast track designation for its lead cancer drug VT3989, a first-in-class TEAD autopalmitoylation inhibitor for use in...
FDA warns Garland, TX-based Naturich Cosmetique about CGMP violations in its production of finished drugs.
FDA says Trividia Health has recalled 601 blood glucose meters that may have defective LCD displays.
