A new analysis from investment firm Jefferies finds that nearly three-quarters of drug candidates that received an FDA breakthrough therapy designatio...
FDA clears a Methinks AI 510(k) for its Methinks CTA Stroke, an artificial intelligencebased software tool that detects suspected large vessel occlusi...
FDA releases the form FDA-483 with eight observations from an inspection at the Aurobindo Pharma drug manufacturing facility in Bachupally, Hyderabad,...
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 ...
