Clinical Trial News
FDA Approves Rybrevant (amivantamab-vmjw) Plus Lazcluze (lazertinib) for Patients with EGFR-Mutated Advanced Lung cancer
FDA approves Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for first-line treatment of EGFR-mutated advanced NSCLC, marking a significant development for patients with unmet needs.
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Tirzepatide Reduced the Risk of Developing Type 2 Diabetes by 94% in Adults with Pre-Diabetes and Obesity or Overweight
Tirzepatide reduced the risk of developing type 2 diabetes by 94% in adults with pre-diabetes and obesity or overweight, and resulted in sustained weight loss over a three-year treatment period.
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Regeneron Provides Update on Biologics License Application for Linvoseltamab
FDA issued a Complete Response Letter for Regeneron's linvoseltamab BLA in R/R MM; issue relates to a third-party fill/finish manufacturer. Regeneron working with manufacturer and FDA to resolve and bring linvoseltamab to R/R MM patients. EMA review ongoing. Linvoseltamab is investigational, not yet approved.
GSK Receives US FDA Breakthrough Therapy Designation for B7-H3-Targeted Antibody-Drug Conjugate GSK5764227 in Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer
GSK receives US FDA Breakthrough Therapy Designation for B7-H3-targeted ADC GSK5764227 in relapsed or refractory ES-SCLC.
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U.S. FDA Grants Tentative Approval of Yutrepia (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
The U.S. FDA has granted tentative approval to Yutrepia (treprostinil) inhalation powder for treating PAH and PH-ILD, pending the expiration of a competing product's exclusivity. Liquidia plans to challenge the FDA's grant of exclusivity to United Therapeutics for Tyvaso DPI to expedite Yutrepia's full approval.
Arthrosi Therapeutics Receives FDA Fast Track Designation for AR882 in Tophaceous Gout
Arthrosi Therapeutics receives FDA Fast Track Designation for AR882 in treating tophaceous gout, a serious condition affecting 2 million gout patients in the U.S. AR882, a next-generation URAT1 inhibitor, aims to address this unmet medical need.
Enrollment Completed for Phase 2 Clinical Trial Evaluating VG081821AC for the Treatment of Parkinson's Disease
Vimgreen Pharmaceuticals completed enrollment for its Phase 2 trial of VG081821AC, an A2A receptor antagonist for early-to-mid stage Parkinson's disease, with 150 participants. The trial aims to assess VG081821's safety and efficacy as monotherapy, potentially offering a non-dopaminergic treatment option to avoid motor complications associated with long-term L-Dopa use.
Imfinzi Approved in the US for the Treatment of Resectable Non-Small Cell Lung Cancer Before and After Surgery
Imfinzi approved in the US for treating resectable non-small cell lung cancer before and after surgery, based on the AEGEAN trial showing a 32% reduction in risk of recurrence.
U.S. Food and Drug Administration Accepts for Priority Review Deciphera’s New Drug Application for Vimseltinib for the Treatment of Patients with Tenosynovial Giant Cell Tumor (TGCT)
The FDA accepted a priority review for Deciphera's vimseltinib NDA for treating TGCT, with a PDUFA goal date of Feb 17, 2025. Vimseltinib, a CSF1R inhibitor, showed significant efficacy in the Phase 3 MOTION study, presenting an ORR of 40% vs 0% with placebo. The EMA also started its review process for vimseltinib in mid-July.
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Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age
Pfizer and BioNTech announce Phase 3 trial results for their mRNA-based combination vaccine against influenza and COVID-19 in adults 18-64, with one immunogenicity objective met. A separate Phase 2 trial showed robust immunogenicity for standalone influenza mRNA vaccines. The companies are evaluating adjustments to improve immune responses against influenza B and will discuss next steps with health authorities.
