Biotechnology - BioReview (Page 3)

Biotechnology

Intellia's CRISPR Comeback: How Gene Editing Pioneer Navigated Safety Concerns to Resume Pivotal Trials

Intellia Therapeutics announces FDA lift of clinical hold on MAGNITUDE-2 Phase 3 trial for its CRISPR-based therapy targeting hereditary transthyretin amyloidosis, marking a crucial milestone in navigating safety concerns in gene editing.

Biotechnology

Scancell Secures FDA Clearance for Pivotal Phase 3 Melanoma Trial as Novel Immunotherapy Shows 24-Point Survival Advantage

UK-based Scancell Holdings announced FDA clearance for its Phase 3 trial of iSCIB1+, a novel DNA immunotherapy for advanced melanoma, following compelling Phase 2 data showing a 24-percentage-point improvement in progression-free survival.

Biotechnology

FDA Accepts First-Ever Quality Control Standard for Mesenchymal Stromal Cells, Setting New Benchmark for Cell Therapy Industry

The FDA's acceptance of Tasly's 3P Characterization of MSCs Assay marks the first FDA-recognized quality control standard for mesenchymal stromal cells, establishing a new benchmark for the cell therapy industry and accelerating the path to consistent, safe, and effective MSC-based therapies.

Biotechnology

Wugen Achieves Historic Milestone: First Allogeneic CAR-T Therapy Earns FDA Breakthrough Status for T-Cell Leukemia

Wugen's soficabtagene geleucel receives FDA Breakthrough Therapy Designation as the first allogeneic CAR-T therapy for T-cell leukemia, marking a transformative milestone in cell therapy innovation.

Biotechnology

Hyundai Bioscience Pioneers Universal Antiviral Approach as XAFTY Advances to Phase 2 Trials Targeting Multiple Viral Threats

Hyundai Bioscience announces Phase 2 FDA trials for XAFTY, a revolutionary broad-spectrum antiviral targeting multiple viral threats including dengue, influenza, COVID-19, and RSV.

Pharmaceuticals

Eli Lilly's Ovarian Cancer Breakthrough: FDA Grants Rare Designation to Novel ADC Targeting Treatment-Resistant Disease

Eli Lilly announced FDA Breakthrough Therapy Designation for sofetabart mipitecan (LY4170156), a novel folate receptor alpha-targeted ADC for platinum-resistant ovarian cancer, offering hope to patients with limited treatment options.

Biotechnology

D3 Bio Advances KRAS-Targeted Cancer Pipeline as FDA Clears Two Critical Clinical Programs

In a significant regulatory milestone that underscores the growing momentum in precision oncology, Shanghai-based D3 Bio announced today that the U.S. Food and Drug Administration has cleared two Investigational New Drug (IND) applications, enabling the company to advance its next-generation KRAS-targeted therapies into critical clinical trials. The dual clearance

Biotechnology

Antengene's Next-Generation Cancer Arsenal Shows Promise as ADC Platform Delivers Strong Clinical Results

Antengene Corporation presented compelling clinical data at the J.P. Morgan Healthcare Conference, showcasing robust efficacy results for its lead antibody-drug conjugate (ADC) and unveiling an ambitious pipeline of next-generation cancer treatments.

Pharmaceuticals

Novartis Achieves Historic Milestone: Ianalumab Becomes First Targeted Therapy to Earn FDA Breakthrough Status for Sjögren's Disease

Novartis announces FDA Breakthrough Therapy Designation for ianalumab in Sjögren's disease, marking the first targeted therapy to receive this recognition for the autoimmune condition.

Biotechnology

Ipsen's Revolutionary Cancer Immunotherapy Earns FDA Breakthrough Status in Blood Cancer Fight

In a significant advancement for cancer immunotherapy, French pharmaceutical company Ipsen announced on January 13, 2026, that the FDA has granted Breakthrough Therapy Designation to IPN60340 (ICT01), a first-in-class monoclonal antibody targeting acute myeloid leukemia (AML). This regulatory milestone positions the therapy as a potentially transformative treatment for one of

Pharmaceuticals

Historic FDA Approval: Zycubo Becomes First Treatment for Menkes Disease, Delivering 10-Fold Survival Improvement

Sentynl Therapeutics receives FDA approval for Zycubo, the first and only treatment for Menkes disease, offering a 10-fold improvement in survival for children with this devastating rare genetic disorder.

Biotechnology

Chinese Biotech Abbisko Challenges Established Players in Rare Tumor Market as FDA Accepts Pimicotinib Application

Abbisko Therapeutics' FDA acceptance of pimicotinib NDA marks a significant regulatory milestone in the competitive TGCT market, challenging established players like Deciphera and Daiichi Sankyo.