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BioPharma Dive1d
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” ...
PharmExec5d
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 ...
Yahoo Finance6d
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 ...
STAT3d
U.S. health officials inject new uncertainty into approval process for Covid boosters
The agency was supposed to decide by April 1 on the company’s application for a full license for its vaccine, known in regulatory terms as a biologics license application, or BLA. The vaccine ...
AbbVie (NYSE:ABBV) Reports US$13 Billion Sales, Submits Application For New Neurotoxin
AbbVie (NYSE:ABBV) recently announced its first-quarter earnings, reporting increased sales year-on-year while experiencing a ...
Ophthalmology Times12d
Aflibercept: Applications for dosing duration and additional indications pending decision with FDA and EMA
Regeneron aims for FDA approval of extended dosing for EYLEA HD in AMD and DME, with a decision by April 2025. Pre-filled ...
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 ...