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FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy
The Woonsocket Call· 2 days agoToday, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy ...
Duchenne approval exposes FDA rift over Sarepta gene therapy
BioPharma Dive via Yahoo Finance· 2 days agoPeter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could...
FDA Approves Skyrizi for Ulcerative Colitis
Medscape· 4 days agoThe approval is the fourth indication for the anti–interleukin 23 monoclonal antibody after approval for Crohn's disease, psoriatic arthritis, and plaque...
Menthol-flavored vapes just got FDA approval
Quartz· 2 days agoThe Food and Drug Administration announced Friday that it has authorized the marketing of four menthol-flavored e-cigarette products from NJOY. “It is...
FDA clears NJOY e-cigarette products after 'extensive' review
United Press International via Yahoo News· 1 day agoFood and Drug Administration on Friday cleared four NJOY menthol-flavored e-cigarette products to be...
Argenx Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy Treatment
Market Watch· 1 day agoPublished: June 21, 2024 at 5:47 p.m. ETShareResizeBy Sabela OjeaAbout Dow Jones NewswiresDow Jones Newswires is a market-moving financial and business news source, used by wealth managers, ...
AbbVie's (ABBV) Skyrizi Gets FDA Nod for Ulcerative Colitis
Zacks via Yahoo Finance· 4 days agoAbbVie ABBV announced that the FDA has granted approval to its blockbuster drug, Skyrizi to treat...
FDA and Abortion Pills: Supreme Court’s Decision Solely About ‘Standing’
National Catholic Register· 20 hours agoFood and Drug Administration’s approval and expansion of abortion pills had nothing to do with...
FDA Expands Pembrolizumab Approval for Endometrial Cancer
Medscape· 5 days agoThe FDA expanded the approval of pembrolizumab based on improved PFS in patients with advanced or...
Top FDA official overrules staff to approve gene therapy that failed trial
Ars Technica· 1 day agoThe Food and Drug Administration (FDA) on Thursday announced expanded approval for a gene therapy to...