Two weeks ago, bluebird bio secured Food and Drug Administration approval for its gene therapy for sickle cell disease, a significant milestone for the roughly 100,000 people in…
Read more Bluebird Bio Stock Is in Free FallPfizer Inc. PFE, -1.73% said Friday that the U.S. Food and Drug Administration has approved the first five-in-one vaccine designed to protect teenagers and young adults against meningococcal…
Read more Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinationsArdelyx Inc. ARDX, -0.58% on Tuesday won its long fight for U.S. regulatory approval of a treatment designed to help patients with chronic kidney disease. The biopharma company…
Read more Ardelyx wins long battle for FDA approval of kidney-disease treatmentThe Food and Drug Administration late Friday approved the first-ever pill that can be taken at home for postpartum depression. The medication, called zuranolone, and jointly developed by…
Read more FDA approves first-ever pill for postpartum depression in new mothersThe U.S. Food and Drug Administration on Thursday granted full approval to the Biogen BIIB and Eisai Co. Ltd. ESALF Alzheimer’s treatment Leqembi, a step that secures Medicare…
Read more FDA approves Alzheimer’s treatment Leqembi, clearing the way for Medicare coverageBy Anthony O. Goriainoff AstraZeneca said Thursday that its and MSD’s Lynparza cancer treatment had been approved in the U.S. for the treatment of metastatic castration-resistant prostate cancer,…
Read more AstraZeneca Says US Approved Lynparza as a Prostate Cancer TreatmentThe U.S. Food and Drug Administration said Tuesday it has granted accelerated approval to Biogen Inc.’s torferson, a treatment for a rare form of amyotrophic lateral sclerosis, or…
Read more Biogen wins accelerated FDA approval for treatment for rare form of ALSWASHINGTON (AP) — The Supreme Court on Friday preserved women’s access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit…
Read more U.S. Supreme Court preserves near-term access to abortion pill mifepristoneAUSTIN, Texas (AP) — A federal judge in Texas on Friday ordered a hold on the U.S. approval of the abortion medication mifepristone, throwing into question access to…
Read more Federal judge in Texas suspends FDA approval of abortion pill mifepristoneThe U.S. Food and Drug Administration said Thursday it had reached a final decision to fully withdraw approval of preterm-birth drug Makena and its generics, a full 12…
Read more FDA pulls preterm-birth drug Makena and its generics from market after 12 yearsChina’s top drug regulator said Friday that it approved Merck & Co.’s Molnupiravir for emergency use on Thursday, as the country grapples with waves of infections after Beijing…
Read more China Approves Merck’s Molnupiravir for Emergency Use, Regulator Says
