FDA grants Reflection Biotechnologies an orphan drug designation for RBIO-101, an adeno-associated virus gene therapy product for treating Bietti's Cr...
FDA releases its latest batch of Warning Letters that includes one medical product company Kelley-Ross Compounding.
Federal Register notice: FDA determines that chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis satisfy its tropical disease ...
Federal Register notice: FDA determines that Pneumocystis pneumonia does not meet statutory criteria for designation as a tropical disease.
FDA proposes to ban three bulk drug substances bumetanide, nicardipine hydrochloride, and vasopressin from its list of bulk drug substances (active ...
Stakeholders ask for clarifications to an FDA draft guidance on assessing drugs pressor effects.
Former FDA commissioner Robert Califf and Verily Life Sciences researchers suggest it is possible to use digital measurement tools and analytics to mo...
FDA approves a Shire BLA for Takhzyro (lanadelumab-flyo) injection for preventing hereditary angioedema attacks in patients 12 years of age and older.