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Duchenne approval exposes FDA rift over Sarepta gene therapy
BioPharma Dive via Yahoo Finance· 1 day agoPeter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could...
Pharma Stock Roundup: FDA Nod to MRK's New Jab & Expanded Use of ABBV & AZN Drugs
Zacks via Yahoo Finance· 22 hours agoFDA approves Merck's (MRK) 21-valent pneumococcal conjugate vaccine, Capvaxive and the expanded use...
US FDA clears Kyverna’s KYV-101 cell therapy for Phase II SPS trial
Clinical Trials Arena via Yahoo Finance· 1 day agoThe US Food and Drug Administration (FDA) has approved Kyverna Therapeutics’ Investigational New...
Johnson & Johnson seeks FDA approval for Tremfya for Crohn’s disease
Pharmaceutical Technology via Yahoo Finance· 1 day agoThis is the company’s second submission for the therapy in...colitis. The application includes data...
Sarepta's Stock Soars on Best-Case FDA Decision for its Muscular Dystrophy Treatment
The Wall Street Journal· 18 hours agoFor biotech companies, regulatory approval is usually one of many steps needed to convince Wall...
Sarepta Gains as FDA Official Overrules Staff to Approve Therapy
Bloomberg via Yahoo Finance· 21 hours ago(Bloomberg) -- A top US Food and Drug Administration official overrode reviewers to give broad...
FDA approves new drug to treat autoimmune liver disease: ‘Giant step forward’
Fox News via Yahoo News· 1 day agoThe U.S. Food and Drug Administration has approved the French drugmaker Ipsen’s medication Iqirvo...
Did FDA rule change allowing gay, bisexual men to donate blood make a difference?
ABC7 News· 4 days agoFor years, Jose Dominguez, 50, had wanted to donate blood, feeling it was part of his civic duty. In...
FDA official: The risk of secondary cancer from CAR-T therapy is less than feared
Medical Xpress· 5 days agoThe risk of secondary cancer after CAR-T therapy, pioneered at Penn, is less than regulators feared...
COVID summer wave grows, especially in West, with new variant LB.1 on the rise
CBS News· 16 hours agoA summertime wave of COVID-19 infections is arriving earlier than last year across a growing share...