Biotechnology company Revance Therapeutics Inc (Nasdaq:RVNC) revealed on Tuesday that the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection remains under US FDA review for the treatment of glabellar lines in 2021.
Revance said that DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components.
In conjunction, the company provided its response to the Form 483 and is confident in the quality of its DaxibotulinumtoxinA for Injection BLA submission and continues to anticipate FDA approval in 2021. A Form 483 does not constitute a final agency determination.
Lupin announces receipt of US FDA tentative approval for Apixaban Oral Suspension
QIAGEN completes US QIAstat-Dx bloodstream infection portfolio with FDA clearance
Innovent expands global Phase 3 study of IBI363/TAK-928 to include non-squamous NSCLC
FDA approves WELIREG and LENVIMA combination for previously treated advanced renal cell carcinoma
AstraZeneca's IMFINZI combination receives US Priority Review for muscle-invasive bladder cancer
XtalPi submits US FDA IND application for KQTD-126 in chronic intestinal pain
Revvity launches IVDR-certified solution for early detection of type 1 diabetes
FDA Advisory Committee votes in favour of GRAIL's Galleri multi-cancer early detection test
AstraZeneca's Trixeo Aerosphere approved in EU for asthma maintenance treatment
AbbVie secures EU approval for RINVOQ in polyarticular juvenile idiopathic arthritis