Browsing Tag
European Medicines Agency
66 posts
Amgen seeks European approval for teprotumumab in thyroid eye disease
Amgen (NASDAQ: AMGN), a global biotechnology leader, has announced its plans to submit a Marketing Authorization Application (MAA)…
Bristol Myers Squibb’s Opdivo set for EMA approval in urothelial carcinoma
Bristol Myers Squibb (NYSE: BMY), a global leader in biopharmaceuticals, has reached a significant milestone with the Committee…
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…
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…
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.…
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…
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…
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…
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…
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,…