Europe – EMA recommends approval of Imvanex for the prevention of monkeypox disease
EMA’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease.
The medicine has been approved in the EU...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Nine new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2023 meeting.
The CHMP recommended granting a marketing authorisation for Ebglyss (lebrikizumab), for...
UK – SKYCovion COVID-19 vaccine authorised by MHRA
SKYCovion, the COVID-19 vaccine developed by SK Chemicals, has today been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the 8th...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November –...
EMA recommends withdrawal of pholcodine medicines from EU market
EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults...
Europe – EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy whose disease...
Europe – Health Technology Assessment : Guidance on reporting requirements for multiplicity issues and...
This guidance describes how to deal in practice with multiplicity issues and
complementary analyses (like specific subgroup analyses, specific post hoc analyses and sensitivity analyses)...
Europe – New features further strengthen Priority Medicines scheme (PRIME)
EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of...
UK – NICE nod for Darzalex with lenalidomide and dexamethasone
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the National Institute for Health and Care Excellence (NICE) has recommended Darzalex –...
Europe – Precautionary measures to address potential risk of neurodevelopmental disorders in children born...
On 24 January 2024, the CMDh1 endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures...
UK – Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary...
Pholcodine-containing cough and cold medicines are being withdrawn from the UK market as a precaution following a review which found that their benefits...
