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Cell & Gene

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Dr...

February 21, 2024 | News

Neurophth Completes Enrollment for Opvika® LHON Gene Therapy Trial in the U.S.

Neurophth Therapeutics, Inc. ("Neurophth"), a pioneer in gene therapies, today announced the successful completion of patient enrollment for its Phase I/II...

February 20, 2024 | News

Melanoma Research Alliance Applauds FDA Approval of First Cellular Therapy in Melanoma

AMTAGVI marks the first individualized Tumor Infiltrating Lymphocyte (TIL) therapy to receive FDA approval for any cancer. In this innovative thera...

February 17, 2024 | News

FDA Prioritizes Review of Bristol Myers Squibb's Augtyro™ for NTRK-Positive Solid Tumors

Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for A...

February 15, 2024 | News

Atara Biotherapeutics Submits Investigational New Drug Application for ATA3219 to Treat Lupus Nephritis

Lupus nephritis, a condition affecting the kidneys, presents a challenging treatment landscape with limited efficacy from existing therapies. ATA32...

February 15, 2024 | News

Multiply Labs, Thermo Fisher Expand Partnership for Cell Therapy Automation

Through integration with Multiply Labs' robotic technology, Thermo Fisher Scientific’s advanced, industry-leading cell therapy instruments, including...

February 13, 2024 | News

BioNTech's $200 Million Investment in Autolus Marks Milestone in Strategic CAR-T Collaboration, Revolutionizing Cancer Therapy

Strategic alliance leverages manufacturing and commercial infrastructure as well as technology with the aim to advance both...

February 08, 2024 | News

AstraZeneca Boosts US Manufacturing to Accelerate Cell Therapy Advancements

AstraZeneca is investing $300 million in a state-of-the-art facility in Rockville, MD to launch its life-saving cell therapy platforms in the US for critic...

February 07, 2024 | News

Acepodia Gains FDA Clearance for ACE2016, Initiates Phase 1 Study on Solid Tumor Treatment

This clearance marks a significant milestone for Acepodia, allowing the initiation of a Phase 1, first-in-human clinical trial to assess th...

February 05, 2024 | News

Sirius Therapeutics Begins Phase 1 Trial for Long-Acting Factor XI siRNA Anticoagulant

"This study is based on in vivo studies that have demonstrated a nearly 100% reduction in FXI levels for up to 6 months without bleeding events a...

February 04, 2024 | News

Biosyngen's BST02 Granted FDA Fast Track for Liver Cancer Treatment

Fast track is a process designed to facilitate development, and accelerate the review of drugs to treat serious or life-threatening conditions and fill an ...

February 02, 2024 | News

Singleron Introduces AccuraSCOPE® Single Cell Transcriptome Platform

AccuraSCOPE Single Cell Transcriptome and Genome Library Kit opens new possibilities for single cell multi-omic analysis by profiling the entire geno...

January 31, 2024 | News

Vertex's Breakthrough VX-548: Transforming Pain Management with Rapid Relief and Safety, A New Era in Acute Pain Solutions

Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from ...

January 31, 2024 | News

CellVax Therapeutics Receives FDA Clearance for FK-PC101 Cancer Immunotherapy IND

FK-PC101 is CellVax's novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatec...

January 30, 2024 | News

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