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FDA approves Biotest’s plasma-derived treatment for immunodeficiencies
BioPharma-Reporter· 20 hours agoYimmugo, an intravenous immunoglobulin therapeutic, is the first therapy developed by Biotest to be...
US FDA approves expanded use of Sarepta's Duchenne gene therapy; shares jump
AOL· 11 hours agoThe agency gave traditional approval to patients four years and above who can walk, as well as accelerated approval for those who cannot. The FDA gave accelerated approval ...
Dollar Tree gets FDA warning letter over recalled applesauce pouches
Consumer Affairs· 19 hours agoThe product was pulled from store shelves – but apparently, not all store shelves. The U.S. Food and Drug Administration (FDA) has sent a warning letter to Dollar Tree, telling ...
FDA say Dollar Tree did not pull lead-contaminated applesauce from shelves for months
WSOC-TV Charlotte· 1 day agoThe FDA said that it sent out a warning letter to Dollar Tree earlier this month, The Associated...
US FDA approves expanded use of Sarepta's Duchenne gene therapy; shares jump
Reuters via Yahoo News· 11 hours ago(Reuters) -The U.S. Food and Drug Administration allowed the expanded use of Sarepta Therapeutics'...
FDA Ban On Shock Devices For Those With Developmental Disabilities Faces New Hurdle
Disability Scoop· 1 day agoA bill making its way through the U.S. House of Representatives would limit the FDA’s ability to do...
FDA took months to react to complaint about Abbott infant formula factory, audit finds
WNDU 16 South Bend· 7 days agoThe Department of Labor received the email and three days later forwarded it to an FDA address...
...States with First Commercial Doses Administered Just Weeks After FDA Approval—Opening New Era for...
Morningstar· 20 hours agoImmunityBio Announces Insurance Coverage of ANKTIVA® Across Multiple States with First Commercial Doses Administered Just Weeks After FDA Approval—Opening New Era for Immunotherapy ...
Global Nonprofit CureDuchenne to Host Informational Webinars Following FDA Label Expansion of...
FOX 23 News Albany· 8 hours agoFood and Drug Administration (FDA) approved the expansion to the label indication for ELEVIDYS (delandistrogene moxeparvovec-rokl) from Sarepta Therapeutics to include individuals ...
Gene Therapy for Kids’ Deadly Disease Wins Broader FDA Approval
Bloomberg· 11 hours agoSarepta Therapeutics Inc.’s gene therapy received expanded US approval to include more children with...