Category Regulatory

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced full results from the non-registrational Phase 2 KeyVibe-002 trial evaluating vibostolimab/pembrolizumab, an investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy,…

AstraZeneca has decided to discontinue the STABILIZE-CKD and DIALIZE-Outcomes Phase III evidence trials for Lokelma (sodium zirconium cyclosilicate). The decision was made due to substantially increased enrolment timelines and low event rates, respectively, which made it prohibitive to deliver study results within…

The “Transmucosal Drug Delivery Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2023 Update” report has been added to ResearchAndMarkets.com’s offering. The report provides comprehensive information about the Transmucosal Drug Delivery pipeline products with comparative analysis of…

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it launched Phesgo® combination for Subcutaneous Injection MA, IN [generic name: pertuzumab (genetical recombination), trastuzumab (genetical recombination) and vorhyaluronidase alfa (genetical recombination) ] (hereafter, Phesgo), antineoplastic agent / anti-HER2 humanized monoclonal antibody for the…

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment…

AstraZeneca’s Imfinzi (durvalumab) has been approved in China for the 1st-line treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin). Imfinzi plus chemotherapy was approved in China as the first immunotherapy…

FDA approves Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO)  Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (U.S. FDA) has approved Vabysmo® (faricimab) for the treatment of macular edema…

Soliris approved in China for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) The approval by the National Medical Products Administration (NMPA) in China was based on results from the Phase III PREVENT trial.1 In the trial, Soliris met the primary…

FDA Approves PENBRAYA™, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal…

European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin,…

.S. FDA Approves Pfizer’s VELSIPITY™ for Adults with Moderately to Severely Active Ulcerative Colitis (UC) Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor…