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EMA reports big wins for small pharma

Written by | 16 Jul 2021

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.

Nefecon filed with EMA for primary IgA Nephropathy – Calliditas Therapeutics

Written by | 7 Jun 2021

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.

CHMP recommends approval of Klisyri for actinic keratosis – Almirall

Written by | 25 May 2021

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.

EU gives green light for new medicines

Written by | 12 May 2021

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.

EMA and ECDC join forces to monitor COVID-19 vaccines

Written by | 11 May 2021

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.

EMA validates MAA for Trodelvy under accelerated review in triple-negative breast cancer – Gilead Sciences

Written by | 6 Apr 2021

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.

EMA validates MAA for relugolix for the treatment of advanced prostate cancer – Myovant Sciences

Written by | 5 Apr 2021

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.

EMA backs six new medicines

Written by | 14 Mar 2021

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:

EMA plans rapid approval of vaccines against COVID-19 variants

Written by | 12 Mar 2021

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.

EU approved 96 new medicines in 2020

Written by | 14 Jan 2021

The European Medicines Agency gave its backing to 15 new medicines at its December meeting, taking its total for the year to 96.

EU watchdog approves 10 new drugs

Written by | 3 Dec 2020

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.

EU regulator steps up transparency on COVID-19 therapies

Written by | 3 Dec 2020

Article written by Gary Finnegan The European Medicines Agency (EMA) has implemented extra transparency measures for COVID-19 treatments and vaccines.

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