BioSpace News Archive

Drug Development

Ascentage Pharma Received Clearance from U.S. FDA to Proceed with Global Registrational Phase III Clinical Trial for Lisaftoclax (APG-2575) in Previously Treated Patients with CLL/SLL

Ascentage Pharma announced that lisaftoclax, a novel Bcl-2 inhibitor and one of the company’s core assets, has been cleared by the US Food and Drug Administration to enter a global registrational Phase III study for treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who were BTKi previously treated.

August 6, 2023
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7 min read
Policy

VenusP-Valve granted IDE approval for clinical trial, unveiling a new chapter for Chinese valve solutions globally

Recently, Venus Medtech Inc., a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced the Investigational Device Exemption full approval for its in-house developed VenusP-Valve from the U.S. Food and Drug Administration.

August 6, 2023
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3 min read
Drug Development

Bavarian Nordic Reports Positive Phase 3 Topline Results for Chikungunya Virus Vaccine in Adults and Adolescents

Bavarian Nordic A/S announced positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of its virus-like particle -based chikungunya virus vaccine candidate, CHIKV VLP in adults and adolescents aged 12 to 64 years of age.

August 6, 2023
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5 min read