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...
Corbus says that after a meeting with FDA it will change the primary efficacy endpoint for its RESOLVE-1 lenabasum trial for treating systemic scleros...
The Supreme Court is expected to decide soon whether to hear an appeal of a case involving the adequacy of a suicide warning in the label for generic ...
FDA approves an Akorn ANDA for an over-the-counter version of GlaxoSmithKlines Flonase (fluticasone propionate) nasal spray USP, 50 mcg per spray, ind...