FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older
Astellas Pharma Inc. announced that FDA has acknowledged the company’s resubmission of the Biologics License Application for zolbetuximab, a first-in-class investigational claudin 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.
The European Commission has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Based on data from the first year of the three-year NHS-Galleri trial, NHS England has decided that it will wait to see final results, expected in 2026, before considering whether an NHS rollout of the Galleri multi cancer early detection test (the Multi Cancer Blood Test Programme) should go ahead.
The Tartu University Hospital, North Estonia Medical Centre, and Icosagen have joined forces to develop and introduce an innovative personalized cell therapy for patients in Estonia.
Secarna Pharmaceuticals GmbH & Co. KG, an independent European antisense drug discovery and development company, and Orbit Discovery Ltd., a leader in the discovery of therapeutic peptide hits, announced a collaboration to discover and develop peptide-conjugated targeted antisense oligonucleotide therapeutics.
Cartography Biosciences Inc. has entered a strategic collaboration agreement with Gilead Sciences Inc., to discover and develop therapies for patients with triple-negative breast cancer and the most common form of non-small cell lung cancer, adenocarcinoma.
FDA’s Medical Devices Advisory Committee has strongly recommended FDA approval of Guardant Health’s Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease.
FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.
FDA has reassigned the previously announced Prescription Drug User Fee Act goal date of Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20).
