The European Medicines Agency (EMA) has recommended seven medicines for approval at its October 2023 meeting. The brings the total number of newly approved medicines this year to 62. The Agency’s committee on human medicines (CHMP) approved the following: Agamree(vamorolone), for the treatment of Duchenne muscular dystrophy, a genetic disorder characterised by the progressive loss of muscle function. Elrexfio(elranatamab), conditionally authorised […]
The European Medicines Agency (EMA) is warning patients and healthcare professionals to beware of pre-filled pens falsely labelled as Ozempic, a diabetes medicine linked to weight loss. National authorities notified the EU regulator after the pens, which are labelled in German and appear to have originated from wholesalers in Austria and Germany, were found in several locations in the EU […]
EU medicines regulators have approved a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunisation of infants from birth through 6 months of age following administration of the vaccine to the mother during pregnancy. This vaccine is also indicated for active immunisation of adults aged 60 years […]
Important information about cancer drug benefits, and related uncertainties, is frequently omitted from official prescription drug information sources for clinicians and patients in Europe, finds an analysis published by The BMJ today. Despite the commitment of medicines regulators to shared decision making and person centred care, the researchers say better information on the benefits and potential harms of medicines are needed to […]
The European Medicines Agency (EMA) has approved four new medicines at its January meeting, getting 2023 off to a low-key start. The Agency’s key human medicines committee (CHMP) recommended granting a marketing authorisation for Sotyktu (deucravacitinib) – a medicine for the treatment of moderate to severe plaque psoriasis in adults, a skin disease causing red, scaly patches. The committee adopted positive opinions […]
The European Medicines Agency (EMA) has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of patients in the EU. These include new technologies, digitalisation, novel materials and novel devices. The role of the QIG is to ensure that the European medicines regulatory network keeps pace with innovation, […]
The number of people in Europe dying because of antimicrobial resistant (AMR) infections has hit an all time high, according to new EU data. An estimated 35,000 Europeans die every year, while drug-resistant infections are responsible for €1.5 billion extra healthcare costs and productivity losses. The European Medicines Agency (EMA), the EU’s medicines watchdog, says it is playing its part […]
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