News about "European Medicines Agency "

Italfarmaco, JCR Sign License Deal for Hunter Syndrome Therapy

JCR Pharmaceuticals and Italfarmaco expand their rare disease collaboration with a global license agreement for JR-141.

European Medicines Agency | 05/10/2026 | By News Bureau

Litfulo Shows Significant Repigmentation Benefits in Phase 3

Pfizer’s two phase 3 trials showed significant improvements in facial and total body repigmentation compared with placebo.

European Medicines Agency | 05/10/2026 | By News Bureau

Merck Gets Positive EU Opinion for Keytruda-Padcev in MIBC

Merck’s Keytruda plus Padcev receives a positive CHMP opinion for perioperative treatment of adults with resectable muscle-invasive bladder cancer, with the EC set to review the recommendation.

European Medicines Agency | 19/09/2026 | By News Bureau

FDA Approves Regeneron's Pasatru to Reduce New Bone Formation in FOP

Regeneron’s Pasatru has received FDA approval for adults with FOP, with Phase 3 OPTIMA data showing up to a 94 percent reduction in new heterotopic ossification lesions compared with placebo.

European Medicines Agency | 24/08/2026 | By News Bureau |  616

Pfizer and Valneva's Lyme Disease Vaccine Candidate Moves to EMA Review

Pfizer and Valneva’s investigational Lyme disease vaccine PF-07307405 has received EMA validation for its Marketing Authorization Application, triggering the European regulatory review.

European Medicines Agency | 17/08/2026 | By News Bureau |  100

European Commission Expands Sanofi's MenQuadfi Approval to Include Infants from Six Weeks of Age

The European Commission has approved an expanded indication for Sanofi's MenQuadfi vaccine, allowing immunisation of infants from six weeks of age against invasive meningococcal disease caused by serogroups A, C, W and Y.

European Medicines Agency | 05/08/2026 | By News Bureau |  102

European Commission Approves Pfizer-BioNTech's XFG-Adapted COVID-19 Vaccine for 2026-27 Season

The European Commission has approved Pfizer and BioNTech's monovalent XFG-adapted COVID-19 vaccine for the 2026–27 vaccination season that authorised for people aged six months and above, is designed to enhance protection against currently circulating SARS-CoV-2 variants and will be supplied across the European Union and selected European countries.

European Medicines Agency | 31/07/2026 | By News Bureau |  133

Philogen Resubmits EMA Marketing Application for Melanoma Therapy Nidlegy with Updated Phase 3 Data

Philogen has resubmitted its EMA marketing application for investigational melanoma therapy Nidlegy, supported by updated Phase 3 clinical data demonstrating reduced risk of relapse or death and an extended patient follow-up period.

European Medicines Agency | 28/07/2026 | By News Bureau |  153

CHMP Recommends EU Approval for NewAmsterdam Pharma's Obicetrapib Therapies to Treat High Cholesterol

NewAmsterdam Pharma and Menarini have received a positive CHMP opinion for Ubeslo and Evlarco, bringing the oral obicetrapib-based therapies one step closer to EU approval for patients with hypercholesterolaemia and mixed dyslipidaemia.

European Medicines Agency | 27/07/2026 | By News Bureau |  187

EMA Backs Marketing Authorisation for Janssen's Icotyde in Plaque Psoriasis

CHMP backs marketing authorisation for icotrokinra to treat moderate-to-severe plaque psoriasis in adults and eligible adolescents, potentially making it the first oral IL-23-targeting therapy approved in the EU.

European Medicines Agency | 27/07/2026 | By News Bureau