Tag: Drug Approvals
FDA Approves First Immunotherapy Drug for Breast Cancer
Combo of Tecentriq and chemo given accelerated approval for triple-negative breast cancer
FDA Approves Ketamine-Like Drug for Severe Depression
Drug available through restricted distribution system, must be administered in certified medical office
FDA Approves First Customizable Insulin Pump
Product works by delivering insulin under the skin at set or variable rates
FDA Approves Cablivi for Rare Blood-Clotting Disorder
Drug approved to treat adults with acquired thrombotic thrombocytopenic purpura
FDA Approves First Generic Version of Advair for Asthma, COPD
Medication approved to treat children aged 4 or older with asthma, adults with asthma or COPD
FDA Approves First Generic Version of Epilepsy Drug Sabril
Generic equivalents held to same vigorous manufacturing standards as brand-name drugs
FDA Down to 5 Weeks of Funding to Review New Drug Applications
Agency cannot accept new fees or applications until the shutdown is over
FDA Approves Drugs for Treatment of Two Rare Blood Diseases
Elzonris approved to treat BPDCN; Ultomiris approved for paroxysmal nocturnal hemoglobinuria
FDA Approves Firdapse for Rare Autoimmune Disorder
First agency-sanctioned treatment for adults with Lambert-Eaton myasthenic syndrome
FDA Approves Treatment for AML Patients With Gene Mutation
Expanded approval also granted to mutation assay used to detect FLT3 mutation in AML patients
