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 CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunization of infants from birth through six months of age following administration of the vaccine to the mother during pregnancy. It is also indicated for […]
Merck Inc., known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, developed for the treatment for adults with refractory or unexplained chronic cough. The CHMP’s recommendation will now be […]
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 […]
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression greater than 1% who are at a high risk of recurrence after undergoing radical resection. The European Commission (EC), […]
Myovant Sciences announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The European Commission will review […]
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Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]
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