Tag: Drug Approvals
FDA Approves Novel Treatment for Hairy Cell Leukemia
Lumoxiti, a CD22-directed cytotoxin, approved for adults who have had at least two prior therapies
FDA Approves New Treatment for Opioid Dependence
The sublingual buprenorphine and naloxone combo should be part of a complete treatment plan
FDA Approves First Drug for Neurotrophic Keratitis
Oxervate, a topical eye drop, led to complete corneal healing among 70 percent of study participants
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
