The U.S. Food and Drug Administration approved Pfizer Inc.’s Xeljanz XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis, after an inadequate response or intolerance to TNF blockers.
The U.S. Food and Drug Administration approved Amgen Inc.’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis (RA) drug Remicade.
AstraZeneca Plc and Merck & Co. Inc.’s Lynparza won approval in China as a first-line treatment for a form of ovarian cancer.
The U.S. Food and Drug Administration approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer.
The U.S. Food and Drug Administration approved an expanded indication for Sanofi’s Toujeo (insulin glargine injection) for blood sugar control in adult and pediatric patients who are ages 6 years and older. The expanded indication approved by the FDA applies to both type 1 and 2 diabetes. Previously, Toujeo was U.S.-approved only for adults aged 18 years and older.
The U.S. Food and Drug Administration approved Oxbryta (voxelotor), a drug from Global Blood Therapeutics Inc. developed to treat sickle cell disease in adults and children 12 years or older.
Shares of Aquestive Therapeutics were up more than 18 percent following approval from the U.S. Food and Drug Administration for Exservan, a treatment for amyotrophic lateral sclerosis (ALS).
SK Biopharmaceuticals and U.S. subsidiary SK Life Science announced that the U.S. Food and Drug Administration approved Xcopri (cenobamate tablets) for partial-onset seizures in adults.
AstraZeneca shares rose 2.7 percent after the British drugmaker won earlier-than-expected U.S. regulatory approval for a leukemia drug, in a challenge to rival AbbVie.
Alnylam Pharmaceuticals Inc. priced the company’s gene silencing drug to treat patients with a rare genetic disorder that can cause severe pain at $575,000 per year after receiving an early U.S. approval.
