Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022. Pfizer and BioNTech completed the rolling submission of the BLA in May 2021. The application
AbbVie Submits Biologics License Application to the FDA for ...
NORTH CHICAGO, Ill., Sept. 27, 2024 / PRNewswire / -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth ...
2024 Biological Approvals | FDA - U.S. Food and Drug Administration
Feb 16, 2024 · See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs)...
Eisai Initiates Rolling Biologics License Application to US FDA for ...
May 15, 2024 · Eisai submitted to the FDA a Supplemental Biologics License Application (sBLA) for monthly LEQEMBI intravenous (IV) maintenance dosing in March 2024.
Development & Approval Process (CBER) | FDA - U.S. Food and …
May 4, 2023 · The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).
Pfizer and BioNTech Initiate Rolling Submission of Biologics License ...
May 7, 2021 · NEW YORK & MAINZ, Germany-- (BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.
Fresh from the biotech pipeline: record-breaking FDA approvals
Feb 26, 2024 · Small-molecule New Drug Application (NDA) approvals outnumbered Biologics License Application approvals in 2023, but only just: 48% of new approvals were biologics, a share beaten just once, in...
Biologics License Applications (BLA) Process (CBER) | FDA
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated...
Fresh from the biotech pipeline: fewer approvals, but biologics …
Jan 9, 2023 · With over 130 active biologic license applications and new drug applications underway, according to BioMedTracker, there is plenty of scope for US approvals to pick up again in 2023.
Janssen Submits Supplemental Biologics License Application to …
Nov 20, 2023 · In August 2023, Janssen submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for the expanded approval of RYBREVANT ® in combination with...