Business Wire

VectorBuilder Powers FDA IND Approval of World’s First Umbilical Cord Blood-Derived Allogeneic CAR-T Product

UC101 is the world’s first FDA IND-approved umbilical cord blood-derived allogeneic CAR-T therapy. T cells derived from umbilical cord blood possess the natural advantages of low immunogenicity and ...
The Manila Times

Belief BioMed Congratulates Partner AskBio on IND Acceptance by FDA for Investigational Gene Therapy for Late-Onset Pompe Disease

AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, recently announced that the United States Food and Drug Administration (FDA) has ...
Healio

FDA accepts IND for allogeneic CAR T-cell therapy that could bypass lymphodepletion

Please provide your email address to receive an email when new articles are posted on . The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen ...
The Barre-Montpelier Times Argus

4Moving Biotech Receives FDA IND Clearance for 4P004, Strengthening Its Position as a Leading Innovator in Disease-Modifying Osteoarthritis Therapeutics

Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for ...
Seeking Alpha

Incannex Completes Positive Pre-IND Meeting with US FDA on IHL-675A for Treatment of Rheumatoid Arthritis

MELBOURNE, Australia, July 26, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal ...
JD Supra

FDA Outlines “Plausible Mechanism” Approval Pathway for Personalized Therapies, But Significant Questions Remain

FDA is proposing the PM pathway largely in response to concerns from patient advocates and industry stakeholders that FDA’s existing product approval pathways lack sufficient flexibility for ...

AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD)

AB-1009 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. For more information, ...