FDA issues a draft guidance on information to include in premarket submissions and applications for medical devices with quantitative imaging function...
FDA publishes a draft guidance to assist in development of bispecific antibodies.
FDA publishes a draft guidance on technical considerations specific to medical devices using nitinol.
Friends of Cancer Research chairperson Ellen Sigal says a White House attempt to have all agency guidances reviewed by the Office of Management and Bu...
Mustang Bio reports positive data from a Phase 1/2 clinical trial of a lentiviral gene therapy for treating newly diagnosed infants under two years ol...
FDA clears a RMS Medical Products 510(k) for its High-Flo Super26 Subcutaneous Needle Sets, indicated for subcutaneous infusion of medications in home...
FDA scientists say they have found that using hydroxyurea could lessen the symptoms of sickle cell disease.
FDA grants Viela Bio a breakthrough therapy designation for the companys anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy fo...