FDA Approves First Treatment for Episodic Cluster Headache
The U.S. Food and Drug Administration approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults. “Emgality provides patients with the first FDA-approved drug that reduces the frequency of attacks of episodic cluster headache, an extremely painful and often debilitating condition,” said Eric Bastings, M.D., deputy director of the Division…
FDA Approves New Treatment for Hospital-acquired, Ventilator Associated Bacterial Pneumonia
The U.S. Food and Drug Administration approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA initially approved Zerbaxa in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections.…
FDA Approves Innovative Gene Therapy to Treat Pediatric Patients with Spinal Muscular Atrophy
The U.S. Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality. “Today’s approval marks another milestone in the transformational power of gene…
FDA Approves First Treatment for Children with Rare Autoimmune Disorder
FDA Approves New Treatments for Heart Disease Caused by Serious Rare Disease
First FDA-approved Vaccine for the Prevention of Dengue Disease in Endemic Regions
The U.S. Food and Drug Administration have announced the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in…
FDA Approves New Treatment for Osteoporosis in Postmenopausal Women
The U.S. Food and Drug Administration approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies. More than 10 million people…
FDA Approves First Two-drug Complete Regimen for HIV-infected Patients
The U.S. Food and Drug Administration approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. This is the first FDA-approved two-drug,…
