In a significant development for cervical cancer treatment, Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE: PFE) have announced the European Medicines Agency’s (EMA) validation for review of the marketing authorization application (MAA) for tisotumab vedotin. This antibody-drug conjugate (ADC), developed to treat adult patients with recurrent or metastatic cervical cancer who have progressed on […]
A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc. await the European Medicines Agency’s (EMA) review of their recent application. This significant step involves a Type II variation application for PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab), targeting first-line treatment of adult patients with previously untreated […]
Takeda has announced a significant advancement in the treatment of Hereditary Angioedema (HAE), with the European Commission’s approval of TAKHZYRO (lanadelumab) for routine prevention in patients aged 2 years and older. This approval marks the first long-term prophylactic HAE treatment available in the European Economic Area for patients under six years of age, broadening the […]
LEO Pharma A/S said that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for delgocitinib cream. Touted as a groundbreaking topical pan-Janus kinase (JAK) inhibitor, this cream is specifically designed for adult patients battling moderate to severe chronic hand eczema (CHE). This validation kicks off the official review process by the […]
Biotech leader Can-Fite BioPharma, known for its advances in oncology, inflammatory, and liver diseases, has taken a significant step forward with its announcement today of the submission of a pediatric study plan to the U.S. Food and Drug Administration (FDA). This ambitious move is for the treatment of adolescents with psoriasis using their proprietary drug […]
BeiGene, a global biotechnology firm, has revealed that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for tislelizumab. This treatment is intended for adult patients suffering from unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone platinum-based chemotherapy. “Tislelizumab is the first […]
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist from Merck, also known as MSD outside the United States and Canada. The drug is being developed for adults with refractory or unexplained chronic cough. The European Commission (EC) […]
The Menarini Group and its subsidiary, Stemline Therapeutics Inc., have received a favorable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding the approval of ORSERDU (elacestrant) monotherapy. This treatment is intended for postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer […]
Legend Biotech has announced the submission of a Type II variation application to the European Medicines Agency (EMA) for CARVYKTI (ciltacabtagene autoleucel or cilta-cel), based on data obtained from the CARTITUDE-4 study (NCT04181827). This study focuses on the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have undergone one to three prior […]
Incyte has secured marketing authorization for Opzelura (ruxolitinib) cream 15mg/g from the European Commission (EC) for non-segmental vitiligo with facial involvement in adults and adolescents, aged 12 years and above. Opzelura is a cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib. It has been approved in the European Union (EU) to offer support for repigmentation […]