Apr 06, 2020
Mallinckrodt Initiates Rolling Submission of Biologics License Application for StrataGraft® Regenerative Skin Tissue to U.S. Food and Drug Administration
Dec 23, 2019
BioMarin Submits Biologics License Application to U.S. Food and Drug Administration for Valoctocogene Roxaparvovec to Treat Hemophilia A
Aug 06, 2019
Statement by Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research, on data accuracy issues with recently approved gene therapy
Jul 12, 2019
Halozyme Announces Janssen Submits BLA To FDA For Subcutaneous Formulation Of DARZALEX® Utilizing ENHANZE® Technology
Oct 04, 2018
Ampio Provides Corporate Update
Sep 19, 2018
Leiters Announces New Repackaged Avastin® Under FDA 2018 Guidance
Aug 15, 2018
MiMedx Provides Additional Information and Context to Wall Street Journal Article
Aug 06, 2018
Ampio Hosting Conference Call Tuesday, August 7, 4:30 pm EDT to Update the Preparation of the Biologics License Application (BLA) for Ampion(TM)
Jul 09, 2018
Enzyvant Announces Initiation of RVT-802 Rolling BLA Submission for the Treatment of Complete DiGeorge Anomaly
Jan 14, 2018
WuXi Biologics Appoints Dr. Chiang Syin, a Former FDA Officer as Chief Quality Officer
Dec 22, 2017
BioMarin Receives Anticipated Notification of PDUFA Extension for Pegvaliase Biologics License Application (BLA) to May 28, 2018
Nov 17, 2017
MiMedx Market Leadership Well Positioned In Light Of FDA New Guidance Document
Oct 17, 2017
MiMedx Notified By FDA That It Can Proceed With Phase 2B Investigational New Drug Clinical Trial For Osteoarthritis Of The Knee
Sep 14, 2017
FDA Not Currently Planning to Hold Advisory Committee Meeting for BioMarin's Pegvaliase Biologics License Application (BLA)
Sep 06, 2017
Rebiotix Appoints Edward S. Burd, Ph.D., to Head of Regulatory Affairs
Aug 02, 2017
The U.S. FDA Completed Pre-License Inspection (PLI) of WuXi Biologics cGMP Manufacturing Facilities for Production of TMB-355 (ibalizumab)