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US FDA approves expanded use of Sarepta's Duchenne gene therapy
Reuters· 12 hours agoThe agency gave traditional approval to patients four years and above who can walk, as well as...
Dollar Tree gets FDA warning letter over recalled applesauce pouches
Consumer Affairs· 20 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 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 lifts hold on PTC Huntington’s disease trial
BioPharma Dive via Yahoo Finance· 22 hours agoPerhaps most importantly for the FDA, PTC reported no dose-limiting toxicities in the study. Adverse events were similar across treatment and placebo...
Palatin initiates Bremelanotide-PDE5i Phase II trial for ED
Clinical Trials Arena via Yahoo Finance· 2 hours agoThe trial aims to enrol around 50 participants for an open-label, dose-escalation study. It will...
Global Nonprofit CureDuchenne to Host Informational Webinars Following FDA Label Expansion of...
FOX 23 News Albany· 10 hours agoFood and Drug Administration (FDA) approved the expansion to the label indication for ELEVIDYS (delandistrogene moxeparvovec-rokl) from Sarepta Therapeutics to include individuals ...
McKesson (MCK) Introduces FDA-Approved Prostate Cancer Drug
Zacks via Yahoo Finance· 18 hours agoThe availability of the FDA-approved drug via McKesson's (MCK) independent specialty pharmacy is...
Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA® (guselkumab) for the...
Morningstar· 14 hours agoFood and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active Crohn's disease. The submission ...
US FDA approves expanded use of Sarepta’s Duchenne gene therapy
WSAU Wausau· 12 hours ago(Reuters) -The U.S. Food and Drug Administration allowed the expanded use of Sarepta Therapeutics'...
FDA had 'inadequate' policies to heed warnings about infant formula, probe finds
ABC7 News· 7 days agoThe audit, announced in June 2022, assessed how the agency responsible for the safety of the...
