U.S. Food and Drug Administration– tag –
-
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... -
RNA Therapeutics Advance with Delivery Challenges: mRNA Vaccines, siRNAs, and ASOs Drive Disease Treatment
Facebook (Ambry Genetics) USA Overview Recent publications highlight the profound impact of RNA-based therapeutic modalities, including mRNA vaccines, siRNAs, and ASOs, in treating viral infections, genetic disorders, and cancer. However... -
Boehringer Ingelheim Initiates Phase II for BI 3034701, a Novel GLP-1/GIP/NPY2 Triple Agonist, Reshaping Obesity Treatment
Life Science Daily News USA Overview Boehringer Ingelheim initiated a Phase II trial in July 2026 for BI 3034701 (NCT07662122), a groundbreaking triple agonist targeting GLP-1, GIP, and the NPY2 receptor, signaling a new direction beyond... -
Viral Vector CDMO Capacity Exceeds Clinical Demand: Catalent and Lonza Lead AAV Manufacturing Expansion
IntuitionLabs USA Overview An August 2026 analyst report reveals that viral vector manufacturing capacity, especially for AAV, has outpaced current clinical demand, offering gene therapy sponsors more options and competitive lead times. ... -
FDA Grants Accelerated Approval to Nuvalent’s Zidesamtinib (Jideytro) for ROS1-Positive NSCLC, Two Months Ahead of PDUFA Date
FDA USA Overview On July 22, 2026, the FDA approved Nuvalent, Inc.'s zidesamtinib (Jideytro) for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) previously treated with at least one ROS... -
FDA Grants Accelerated Approval to Regeneron’s Bispecific Antibody Linvoseltamab (LYNOZYFIC) for Multiple Myeloma
International Myeloma Foundation USA Overview The International Myeloma Foundation reported that LYNOZYFIC (linvoseltamab-gcpt), a BCMA-CD3 bispecific antibody immunotherapy, received accelerated FDA approval in July 2025. This drug targ... -
Semaglutide More Than Doubles MASH Resolution Likelihood in Meta-Analysis, Stabilizing Fibrosis
AJMC USA Overview A systematic review and meta-analysis published in Medicine reveals that the GLP-1 receptor agonist semaglutide more than doubles the likelihood of MASH (metabolic dysfunction-associated steatohepatitis) resolution with... -
FDA Approval of First PROTAC Vepdegestrant Raises New Challenges in Targeted Protein Degradation Patent Strategy
Elkington and Fife UK Overview The FDA approval of vepdegestrant, the first PROTAC, marks a significant milestone for targeted protein degradation (TPD), bringing complex intellectual property considerations to the forefront. The unique ... -
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 ... -
2026 RNA Therapeutics Transformation: FDA Approves ASO Olezarsen, siRNA Fitusiran & Plozasiran, Ushering in Diverse Nucleic Acid Era
MiraScope Unknown Overview The year 2026 marks a significant transformation in RNA therapeutics, with multiple approvals solidifying antisense oligonucleotide (ASO) and siRNA therapies as established treatment platforms. Ionis Pharmaceut...
