Tag: European Medicines Agency
Arcturus Therapeutics’ ARCT-032 gets EU’s orphan medicinal product designation for cystic fibrosis
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT), a leading global clinical-stage messenger RNA medicines company, has achieved a significant milestone in the development of treatments for ... Read More
Genmab, Pfizer’s tisotumab vedotin takes a leap towards EU approval for cervical cancer
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 ... Read More
Advancing bladder cancer treatment: EMA scrutinizes Astellas-Pfizer’s innovative therapy
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 ... Read More
Takeda’s TAKHZYRO approved by EC for pediatric hereditary angioedema
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 ... Read More
EMA validates LEO Pharma’s application for delgocitinib cream in chronic hand eczema
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 ... Read More
Can-Fite submits pediatric plan to FDA for Piclidenoson in psoriasis treatment
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 ... Read More
CHMP recommends approval for BeiGene’s tislelizumab in ESCC treatment
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 ... Read More
CHMP endorses Merck’s gefapixant for EU approval for chronic cough treatment
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 ... Read More
Menarini’s ORSERDU gets CHMP positive opinion in advanced breast cancer
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 ... Read More
Legend Biotech announces submission of CARVYKTI application to EMA for multiple myeloma
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 ... Read More