EMA reports big wins for small pharma
The success rate for marketing authorisation applications for small and medium-sized enterprises (SMEs) has doubled between 2016 and 2020, according to the European Medicines Agency (EMA). In 2016,… read more.
The success rate for marketing authorisation applications for small and medium-sized enterprises (SMEs) has doubled between 2016 and 2020, according to the European Medicines Agency (EMA). In 2016,… read more.
Calliditas Therapeutics has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon (budesonide), a novel oral formulation targeting down regulation of IgA1 for… read more.
Almirall S.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the regulatory approval… read more.
Article written by Gary Finnegan. The European Medicines Agency’s (EMA) key committee, known as the CHMP, has recommended approval of eight medicines at its latest meeting. While the… read more.
Article written by Gary Finnegan. The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) has unveiled a new initiative aimed at strengthening post-marketing monitoring… read more.
Gilead Sciences announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for Trodelvy (sacituzumab govitecan-hziy) (SG) for the treatment of adult patients with… read more.
Myovant Sciences announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the… read more.
Article written by Gary Finnegan. The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six medicines for approval at its February 2021 meeting:
Article written by Gary Finnegan. New COVID-19 vaccines against variants of the virus could be approved much more quickly than the first generation of jabs. The European Medicines… read more.
The European Medicines Agency gave its backing to 15 new medicines at its December meeting, taking its total for the year to 96.
Article written by Gary Finnegan. The European Medicines Agency (EMA) has given the green light for ten new medicines at the latest meeting of its influential Committee for… read more.
Article written by Gary Finnegan The European Medicines Agency (EMA) has implemented extra transparency measures for COVID-19 treatments and vaccines.