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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 & JapanSubmission was based on P-IIIb trial (n=1458) assessing immune response & safety…
July 14, 20250Comments

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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 inhibitorsApproval 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, 20250Comments

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Weekly Snapshot

PharmaShots Weekly Snapshots (Jun 07, 2025 – Jul 11, 2025)   

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, and Biosimilars. Check out our full report below:  PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy  Read More: PulseSight Therapeutics BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with…
July 11, 20250Comments

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Merck Animal Health
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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, 2025Bravecto Quantum kills adult fleas and controls flea and tick infestations (Ixodes scapularis, Dermacentor variabilis, Rhipicephalus sanguineus) for 12 mos., and Amblyomma…
July 11, 20250Comments

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Merck new
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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, 2026DOR/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 studyThe…
July 11, 20250Comments

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