Merck & Co.’s Keytruda plus Padcev has won a positive European regulatory opinion for perioperative treatment of resectable muscle-invasive bladder cancer regardless of cisplatin eligibility, potentially expanding an already important oncology franchise into a broader earlier-stage population.
Sanofi plans to transfer 20 mature medicines and manufacturing facilities in France, Hungary and Singapore to Cheplapharm while taking a 26.4% stake in the specialist pharmaceutical company.
Remibrutinib beat teriflunomide on relapse rates and every key secondary endpoint across the Phase 3 REMODEL studies, while avoiding the liver-safety signal that has complicated development of other BTK inhibitors.
AbbVie will present full Phase 3 CERVINO data for etentamig after the BCMA bispecific produced a 74% response rate and reduced progression or death risk by 60% in heavily pretreated multiple myeloma.
SMSbiotech has received an FDA “study may proceed” notification for a Phase 1b U.S. trial of nebulized allogeneic SMS Cells in COPD, with first dosing targeted for the fourth quarter.
The FDA has approved an IBTROZI label update incorporating a 49.7-month median duration of response from the TRUST-I study in TKI-naïve ROS1-positive NSCLC.
Eli Lilly will use the European Association for the Study of Diabetes 2026 meeting to detail Phase 3 retatrutide results, new Foundayo data and the first Phase 2 readout for eloraTZP, revealing how the company intends to segment an increasingly competitive obesity and diabetes market.
The FDA has reduced monitoring requirements around the first two Imdelltra doses, lowering an important logistical burden days after Amgen reported positive Phase 3 survival data in first-line extensive-stage small cell lung cancer.
GSK’s licensed B7-H3 antibody-drug conjugate Ris-Rez delivered median survival of 18.5 months versus 10.3 months with topotecan in a Chinese Phase 3 study, strengthening the company’s case for global development.
Gilead Sciences has expanded six royalty-free licenses to cover investigational once-yearly lenacapavir for HIV prevention, starting manufacturing preparations before the pivotal PURPOSE 365 study has delivered its results.