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Beckley Psytech Receives FDA Investigational New Drug (IND) Approval for Phase IIb study of BPL-003
Tuesday, February 21, 2023Beckley Psytech announced that it had received Investigational New Drug IND approval from the US Food and Drug Administration FDA for a global multisite Phase IIb study exploring the safety efficacy and tolerability of two distinct doses of its lead...
Alnylam Announces U.S. FDA Acceptance of Supplemental New Drug Application for ONPATTRO® (patisiran)
Tuesday, February 21, 2023Alnylam Pharmaceuticals announced that the US Food and Drug Administration FDA has accepted for filing the Companys supplemental New Drug Application sNDA for patisiran an investigational RNAi therapeutic in development for the treatment of the cardi...
Vaxcyte Announces FDA Clearance of Investigational New Drug Application for VAX-24
Tuesday, February 21, 2023Vaxcyte announced that the US Food and Drug Administration FDA has cleared the Companys infant Investigational New Drug IND application for VAX its lead valent pneumococcal conjugate vaccine PCV candidate designed to prevent invasive pneumococcal dis...
FDA Accepts Priority Review for Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults
Tuesday, February 21, 2023Regeneron Pharmaceuticals announced the US Food and Drug Administration FDA has accepted for Priority Review the Biologics Licence Application BLA for pozelimab as a treatment for adults and children as young as year of age with CHAPLE disease also...
FDA Accepts Valneva’s Chikungunya Vaccine Licence Application for Priority Review
Monday, February 20, 2023Valneva announced that the US Food and Drug Administration FDA has completed a filing review of its Biologics Licence Application for Valnevas singleshot chikungunya vaccine candidate VLA and determined that the application is sufficiently complete t...
European Commission Approved CSL's HEMGENIX®, the First Gene Therapy for Hemophilia B
Monday, February 20, 2023Global biotechnology leader CSL announced that the European Commission has granted conditional marketing authorisation CMA for HEMGENIX etranacogene dezaparvovec the first and only onetime gene therapy for the treatment of severe and moderately sever...
Clover Enters into Agreement to Commercialise Quadrivalent Seasonal Influenza Vaccine
Monday, February 20, 2023Clover Biopharmaceuticals announced that it entered into an exclusive agreement with Adimmune Corporation for Clover to distribute AdimFluS QIS in mainland China where it is the only imported quadrivalent seasonal influenza vaccine approved for use i...
Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets
Friday, February 17, 2023Teva Pharmaceuticals a US affiliate of Teva Pharmaceutical Industries announced that the US Food and Drug Administration FDA has approved AUSTEDOXR deutetrabenazine extendedrelease tablets a new oncedaily formulation indicated in adults for tardive d...
U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for PREVYMIS™
Friday, February 17, 2023Merck known as MSD outside of the United States and Canada announced the US Food and Drug Administration FDA has accepted for review two supplemental new drug applications sNDA for PREVYMIS letermovir The FDA granted priority review for the sNDA for...
Charles River and Purespring Therapeutics Announce Gene Therapy Manufacturing Collaboration
Thursday, February 16, 2023Charles River Laboratories International Inc and Purespring Therapeutics announced a plasmid DNA contract development and manufacturing organization CDMO collaboration Under the terms of an agreement Plasmid CDMO alliance supports the first gene ther...
