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Duchenne approval exposes FDA rift over Sarepta gene therapy
BioPharma Dive via Yahoo Finance· 10 hours agoPeter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could...
FDA clears NJOY e-cigarette products after 'extensive' review
United Press International via Yahoo News· 3 hours agoFood and Drug Administration on Friday cleared four NJOY menthol-flavored e-cigarette products to be...
FDA expands approval of first gene therapy for rare form of muscular dystrophy
CNN.com· 6 hours agoThe US Food and Drug Administration has given the green light for the first gene therapy that treats...
Pharma Stock Roundup: FDA Nod to MRK's New Jab & Expanded Use of ABBV & AZN Drugs
Zacks via Yahoo Finance· 8 hours agoFDA approves Merck's (MRK) 21-valent pneumococcal conjugate vaccine, Capvaxive and the expanded use...
Sarepta’ stock soars 38% after FDA expands approval for DMD drug
Market Watch· 10 hours agoThere are about 15,000 cases in the U.S., according to the Muscular Dystrophy Association. The FDA...
FDA gives green light to menthol flavored e-cigarettes for first time
CBS News· 2 hours agoThe Food and Drug Administration on Friday authorized menthol-flavored electronic cigarettes for...
FDA Expands Sarepta's (SRPT) DMD Gene Therapy Label
Zacks via Yahoo Finance· 7 hours agoFollowing the label expansion, Sarepta's (SRPT) Elevidys is approved to treat all DMD patients aged four years and older, regardless of ambulation...
Sarepta Therapeutics Surges on FDA Approval for Expanded ELEVIDY
Guru Focus· 6 hours agoSarepta Therapeutics (SRPT) saw a 36% surge after the FDA approved an expanded indication for ELEVIDYS. The label now includes individuals with Duchenne muscula
Sarepta Gains as FDA Official Overrules Staff to Approve Therapy
Bloomberg via Yahoo Finance· 7 hours ago(Bloomberg) -- A top US Food and Drug Administration official overrode reviewers to give broad ...
Sarepta's Stock Soars on Best-Case FDA Decision for its Muscular Dystrophy Treatment
The Wall Street Journal· 4 hours agoFor biotech companies, regulatory approval is usually one of many steps needed to convince Wall...