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PharmExec7d
AbbVie Submits Biologics License Application to FDA for Novel Serotype E Botulinum Neurotoxin in Moderate to Severe Glabellar Lines
The submission is backed by clinical data from over 2,100 patients, including two pivotal Phase III trials in patients ...
AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines
AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of ...
Morningstar7d
AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE (TrenibotE) for the Treatment of Glabellar Lines
NORTH CHICAGO, Ill., April 24, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA ...
JD Supra1d
Update on Regeneron’s Supplemental BLA for EYLEA HD
Currently, EYLEA HD is approved for dosing intervals of 8-16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). For patients with diabetic ...
BioPharma Dive3d
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...
Morningstar13d
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application
regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD® (aflibercept) Injection 8 mg across all approved ...