The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China, and Japan gave a green lig
There is no evidence of an increased risk of suicidal or self-injurious thoughts and actions with GLP-1 agonists used to treat diabetes and obesity, according to the EU me
Patients in the EU with Fanconi anaemia (FA) could soon have the first gene therapy option for the disorder, as the EMA starts a review of Rocket Pharma’s RP-L102 candidat
The March meeting of the EMA’s human medicines committee (CHMP) saw an approval recommendation for Novartis’ Fabhalta, on track to become the first oral monotherapy for ra
Around 14 months after Eisai and Biogen’s Leqembi was filed for approval in the EU, the bloc’s regulatory authority has delayed making a decision on the Alzheimer’s drug.
Eisai and Biogen’s marketing application for Alzheimer’s disease therapy Leqembi will face an independent advisory committee convened by the EMA before a decision is made
It has been five years since Lexicon Pharma's type 1 diabetes therapy, Zynquista, was rejected by the FDA, and it may struggle to have a better outcome at its second attempt.