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GSK Reports the US FDA’s Application Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease
Shots: The US FDA has accepted application of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs.; FDA decision is anticipated H1’26. GSK is also seeking expanded RSV vaccine indications in other regions, incl. the EEA & Japan Submission was based on P-IIIb trial (n=1458) assessing immune response & safety…
July 14, 2025
Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL
Shots: China’s NMPA has granted conditional approval to lisaftoclax for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received ≥1 systemic therapy incl. BTK inhibitors Approval was based on pivotal P-II (APG2575CC201) trial assessing lisaftoclax monotx. in r/r CLL/SLL pts previously treated with BTK inhibitors &/or immunochemotherapy, which met its 1EP of improved…
July 14, 2025
Eolas Therapeutics Joins Forces with AstraZeneca to Develop AZD4041
Shots: Eolas Therapeutics has secured full development rights from AstraZeneca for AZD4041 to treat opioid use disorder (OUD) and other substance use disorders; terms remain confidential As per the agreement, Eolas will take full responsibility for AZD4041 under the existing IND and advance it to P-II trials with NIDA UG3 support, focusing on a patient-centered…
July 11, 2025
Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study
Shots: Dymicron received the US FDA’s IDE approval to initiate a pivotal trial of Triadyme-C, a cervical artificial disc, to treat symptomatic cervical disc disease (SCDD) across leading US spine centers starting Q4’25 The study will compare the safety and effectiveness of Triadyme-C vs. anterior cervical discectomy and fusion (ACDF). The 1EP of the study…
July 11, 2025
Merck Animal Health
FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Fleas and Ticks
Shots: The US FDA has approved Bravecto Quantum (Fluralaner for Extended-Release Injectable Suspension), a once-yearly injectable for flea and tick protection in dogs, will be available in U.S. veterinary clinics by Aug, 2025 Bravecto Quantum kills adult fleas and controls flea and tick infestations (Ixodes scapularis, Dermacentor variabilis, Rhipicephalus sanguineus) for 12 mos., and Amblyomma…
July 11, 2025
Merck new
Merck NDA for Investigational HIV-1 Two-Drug Regimen DOR/ISL Accepted by US FDA
Shots: The US FDA accepted Merck’s NDA for once-daily oral doravirine/islatravir (DOR/ISL) for virologically suppressed HIV-1 adults; PDUFA target action date: Apr 28, 2026 DOR/ISL showed non-inferiority to bART in open-label P-III MK-8591A-051 and to BIC/FTC/TAF (50mg/200mg/25mg) in P-III MK-8591A-052 at Week 48; the safety profile was generally comparable in the P-III MK-8591A-051 study The…
July 11, 2025
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