The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years
The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
Under the deal, Uniphar will serve as LYMPHIR’s exclusive distribution partner across designated Western and Eastern European territories
Launched in August 2025, GSK India’s Oncology business is rapidly gaining momentum
The board highlighted ongoing investments in Radiopharma, CDMO Sterile Injectables, and CRDMO businesses
The therapy is currently completing Phase 1 clinical trials in renal cell carcinoma and non-small cell lung cancer
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
Subscribe To Our Newsletter & Stay Updated
_256_275.jpeg)
