(Reuters)—The U.S. Food and Drug Administration approved Samsung Bioepis Co. Ltd.’s biosimilar to AbbVie Inc.’s blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday. The drug, Hadlima, was developed by South Korea’s Samsung Bioepis and comes with a boxed warning, the FDA’s harshest. The agency flagged increased risk of serious infections, including tuberculosis…
FDA Approves Drug for Lambert-Eaton Myasthenic Syndrome
(Reuters)—Jacobus Pharmaceutical Co Inc on Monday won U.S. approval for the first drug to treat children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder. The drug, Ruzurgi (amifampridine), was approved for use in patients ages 6–17, the according to the U.S. Food and Drug Administration (FDA). Lambert-Eaton myasthenic syndrome (LEMS), which affects about three people…
FDA Greenlights Osteoporosis Drug for Postmenopausal Women
(Reuters)—The U.S. Food and Drug Administration says it has approved Amgen’s osteoporosis treatment for postmenopausal women who are at high risk of fracture. Evenity (romosozumab-aqqg), developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals. Romosozumab-aqqg belongs to a new…
FDA Approves Combination Therapy for OA Pain, but Not Duobrii Lotion for Plaque Psoriasis
The FDA has approved a combination of amlodipine and celecoxib, which may lower serum creatinine, for treating osteoarthritis pain and hypertension…
IV Tramadol Promising for Postoperative Pain; FDA Denies IV Meloxicam Approval
In its first phase 3 clinical trial, intravenous tramadol has met its primary endpoint for relieving postoperative pain…
FDA Approves Baricitinib for RA Patients
The FDA has approved baricitinib in a 2 mg tablet dose to treat patients with moderate to severe active rheumatoid arthritis…
Certolizumab Pegol Receives FDA Approval for Plaque Psoriasis
On the basis of data from multiple clinical trials, the FDA has approved certolizumab pegol for treating moderate to severe plaque psoriasis…
Ferumoxytol Injection Receives New Indication, & Application for GP2017 Moves Ahead
The FDA recently expanded the indications for ferumoxytol injections to include the treatment of adults with iron-deficiency anemia…
GSK Wins U.S. Shingles Vaccine Approval, U.K. Nod for Gene Therapy
LONDON (Reuters)—GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three key products for which the British drugmaker expects approval this year. It also secured a recommendation from U.K. cost authorities for a $700,000 gene therapy for so-called “bubble boy” disease—a step forward for the field of fixing faulty…
Efficacy Studied Following Accelerated Drug Approvals
In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…