The U.S. Food and Drug Administration today approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.
Category Archives: Food Safety News
FDA authorizes use of first device to treat patients with dialysis-related amyloidosis
The U.S. Food and Drug Administration today authorized use of Lixelle Beta 2-microglobulin Apheresis Column, the first device to treat dialysis-related amyloidosis (DRA).
FDA approves first biosimilar product Zarxio
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the U.S.
FDA expands approved use of Opdivo to treat lung cancer
The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
FDA launches drug shortages mobile app
Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.
FDA approves new antibacterial drug Avycaz
The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
FDA approves Farydak for treatment of multiple myeloma
The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma.
FDA approves Farydak for treatment of multiple myeloma
The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma.
FDA approves closure system to permanently treat varicose veins
The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome
The U.S. Food and Drug Administration today authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder.