Tag: Drug Approvals
FDA Approves Poteligeo for Rare Types of Non-Hodgkin Lymphoma
Drug approved to treat relapsed or refractory mycosis fungoides and Sézary syndrome
FDA Approves Azedra for Rare Adrenal Tumors
First systemic treatment for patients who experience tumor-related symptoms such as hypertension
FDA Approves Magnetic System for Guiding Lymph Node Biopsies
Sentimag System uses magnetic detection to identify sentinel lymph nodes for surgical removal
FDA Approves Tibsovo for Acute Myeloid Leukemia
Approved for adults with relapsed or refractory acute myeloid leukemia who have IDH1 mutation
Trials Supporting FDA Approval of Breakthrough Drugs Examined
Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups
FDA Approves First Drug to Treat Smallpox
New treatment offers additional option should smallpox ever be used as a bioweapon
FDA Approves First Generic Under-the-Tongue Suboxone
May only be prescribed by Drug Addiction Treatment Act-certified prescribers
FDA OKs 1st Biosimilar to Prevent Chemo-Related Infections
Fulphila, biosimilar to Neulasta, helps reduce risk of infection during cancer treatment
FDA Approves First Artificial Iris
CustomFlex Artificial Iris improves light sensitivity and glare, cosmetic appearance of the eye
FDA Approves New Treatment for Ulcerative Colitis
First oral medication approved for chronic use in moderate-to-severe active ulcerative colitis
