FDA approves a UroGen Pharma NDA for Jelmyto (mitomycin gel), indicated for treating low-grade upper tract urothelial cancer.
FDA grants emergency use authorizations to two Covid-19 antibody tests.
Viveve Medical says it has resubmitted an IDE to FDA for approval to conduct the PURSUIT trial of its CMRF treatment for stress urinary incontinence.
Five drug stakeholders comment on a recent FDA/FTC workshop on building a competitive marketplace for biosimilars.
Federal Register notice: FDA withdraws a 3/6 Federal Register notice on a proposed information collection entitled Food and Drug Administration Safety...
FDA grants RemeGen a fast track designation for RC18, a novel recombinant TACI-Fc fusion protein for treating systemic lupus erythematosus.
FDA releases its latest batch of Warning Letters that includes American Fertility Medical Center, HomeChoice Partners and Gaia Arise Farms Apothecary.
Federal Register notice: FDA makes available a final guidance entitled Stability Testing of New Veterinary Drug Substances and Medicinal Products in C...