FDA grants Abeona Therapeutics an Orphan Drug Designation for its EB-101 gene therapy program for patients with dystrophic epidermolysis bullosa.
Federal Register notice: FDA publishes a list of information collections that have been approved by the Office of Management and Budget.
FDA clears a Bio-Rad Laboratories 510(k) for enhanced capability with its IH-Com data management software to manage patient results with the companys ...
Two researchers suggest three policy options for constraining the financial impact on public health insurers of accelerated approval drugs.
Attorney Elizabeth Boggia says a New Jersey federal court decision shows the importance of FDA pre-market approval in preemption defenses.
Attorney James Beck says he expects FDA commissioner Scott Gottlieb to have the agency take a new approach to truthful, non-misleading speech.
Otsuka Pharmaceutical and Proteus Digital Health resubmit an NDA for a drug-device combination product using Abilify (aripiprazole) embedded with a Pr...