UK – AstraZeneca’s rare disease unit receives NICE recommendation for Wolman disease therapy in...
Alexion’s Kanuma (sebelipase alfa), which has been specifically recommended for use in patients who are aged two years or younger when administration begins, will...
UK – MHRA authorises world-first gene therapy for two inherited blood disorders
Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel) is now the first licensed treatment that uses the gene-editing tool CRISPR, for which its inventors...
Europe – EMA seeks feedback on clinical development of vaccines for immunocompromised people
The European Medicines Agency (EMA) has published a draft concept paper on the clinical development of vaccines in immunocompromised individuals. EMA is seeking feedback...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting.
The CHMP adopted a positive opinion for Omjjara* (momelotinib),...
Europe – First electronic product information (ePI) published for selected human medicines
The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across...
UK – MHRA authorises enzyme inhibitor Anastrozole to prevent breast cancer in post-menopausal women
The Medicines and Healthcare products Regulatory Agency (MHRA) has today authorised this new indication for Anastrozole, a hormone treatment used for breast cancer in...
Europe – EMA encourages companies to submit type I variations for 2023 in November...
EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2023 no later than Thursday, 30 November 2023. This will enable EMA to...
Europe – EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus.
The vaccine, known as Nuvaxovid XBB.1.5, is to...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023
GLP-1 receptor agonists: available evidence not supporting link with thyroid cancer
EMA’s safety committee (PRAC) has concluded that the available evidence does not support a...
