Business
FDA’s ODAC votes unanimously that future PI3K inhibitors should include randomized data for blood cancers – Endpoints News
For 20 years, Botox – short for the neurotoxic protein botulinum toxin – has reigned supreme as the most popular cosmetic procedure. Even as Evolus managed to score an FDA approval for a rival product named Jeuveau, its 2021 sales of almost $ 100 million were no match for the $ 2.2 billion revenue AbbVie reported for Botox Cosmetic alone.
But that could change by the end of this year.
Revance, the Nashville, TN-based biotech developing DaxibotulinumtoxinA injection for moderate to severe glabellar lines – a fancy term for frown lines or wrinkles – said the FDA has accepted its BLA resubmission six months after a rejection, which it had blamed on manufacturing issues. It’s given a PDUFA date of Sept. 8.
