Regulatory Pathway– tag –
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ReCode Therapeutics Secures Funding, Partners with Gene Editing Firm to Fast-Track Cystic Fibrosis Gene Therapy with SORT LNP Platform
BioSpace (via Business Wire) USA Overview ReCode Therapeutics has announced new funding from the Cystic Fibrosis Foundation and a strategic partnership with a leading gene editing company. These initiatives will accelerate the developmen... -
FDA Designates Washington University’s WU-CART-007 as Breakthrough Therapy for T-Cell Malignancies: Allogeneic Anti-CD7 CAR T-Cell Therapy Achieves 73% Complete Remission
Siteman Cancer Center at Barnes-Jewish Hospital and WashU Medicine USA Overview The FDA has granted Breakthrough Therapy Designation (BTD) to WU-CART-007, an allogeneic anti-CD7 CAR T-cell therapy developed by Washington University Schoo... -
Merck Achieves Robust Q2 2026 Performance, Upgrades Full-Year Guidance, and Empatran Secures FDA Breakthrough Therapy Designation for Lupus
Merck USA Overview Merck reported strong second-quarter 2026 financial results and consequently upgraded its full-year guidance, bolstered by the U.S. FDA's Breakthrough Therapy Designation for Empatran in July. Empatran, developed for l... -
BMS’s First CELMoD Therapy ZENBEXUS™ Receives Accelerated FDA Approval in Combination with Daratumumab for Multiple Myeloma, Including Early Relapse Patients
Bristol Myers Squibb USA Overview The U.S. FDA granted accelerated approval to Bristol Myers Squibb's first Cereblon E3 ligase modulator (CELMoD) therapy, ZENBEXUS™ (iberdomide), in combination with daratumumab, hyaluronidase-fihj, and d... -
SynaptixBio Accelerates Regulatory Pathway for Ultra-Rare ASO Drugs, Expanding Therapeutic Potential of TUBB4A Mutant Silencers
Advancing RNA USA Overview SynaptixBio is effectively navigating the regulatory landscape for ultra-rare antisense oligonucleotide (ASO) drugs, securing Orphan Drug and Rare Pediatric Disease designations in collaboration with the FDA, E... -
FDA Grants Fast Track and Priority Review to Multiple Cancer Drugs in July 2026: Insilico Medicine’s ISM6331 Receives Designation for Mesothelioma
Pharmacy Times USA Overview In July 2026, the FDA granted Fast Track Designation and Priority Review to several oncology therapeutics, targeting colorectal cancer, anal cancer, malignant pleural mesothelioma, and large B-cell lymphoma. N... -
Daiichi Sankyo’s DXd ADC Pipeline Advances: ENHERTU Files for HER2-Low/Ultra-Low Breast Cancer, Dato-DXd Gains FDA Breakthrough Therapy for EGFRm NSCLC
Quartr Japan Overview Daiichi Sankyo reported significant progress in its DXd antibody-drug conjugate (ADC) pipeline, with ENHERTU showing efficacy in HER2-low and ultra-low breast cancer, leading to global regulatory submissions. Datopo... -
Allogene Therapeutics’ Off-the-Shelf CAR T Cema-Cel Receives FDA RMAT & Fast Track Designations for First-Line MRD-Positive LBCL, Achieves 58.3% MRD-Negativity in Phase 2 Interim Analysis
Allogene Therapeutics Press Release USA Overview Allogene Therapeutics announced that cemacabtagene ansegedleucel (cema-cel), an off-the-shelf anti-CD19 CAR T-cell therapy, received both Regenerative Medicine Advanced Therapy (RMAT) and ... -
Insilico Medicine’s AI-Driven Pan-TEAD Inhibitor ISM6331 Receives FDA Fast Track Designation for Advanced Mesothelioma, Accelerating Development
Insilico Medicine Press Release USA Overview Insilico Medicine announced that its AI-driven pan-TEAD inhibitor, ISM6331, developed using the Chemistry42 platform, received Fast Track Designation from the FDA for advanced malignant pleura... -
FDA Approves Celcuity’s Breakthrough Gedatolisib for Advanced Breast Cancer with Priority Review Designation
Life Science Daily News USA Overview The FDA approved Celcuity's first-in-class PI3K/AKT/mTOR pathway inhibitor, gedatolisib, for advanced breast cancer on its PDUFA date of July 17, 2026. This approval, following Priority Review and Bre...
