News about "European Medicines Agency "

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 |  569

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

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

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

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 |  101

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

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

EMA Committee Recommends Approval of AstraZeneca and Daiichi Sankyo's Enhertu Plus Pertuzumab

If approved, AstraZeneca and Daiichi Sankyo’s Enhertu plus pertuzumab would become first new treatment in the European Union (EU) in more than a decade for first-line HER2-positive metastatic breast cancer.

European Medicines Agency | 25/07/2026 | By News Bureau

FDA Grants Priority Review to Pfizer's Talzenna-Xtandi Combination Advanced Prostate Cancer

Pfizer’s Talzenna-Xtandi combination receives FDA Priority Review for HRR gene-altered metastatic castration-sensitive prostate cancer, with Phase 3 data demonstrating a 52 percent reduction in the risk of disease progression or death.

European Medicines Agency | 24/07/2026 | By News Bureau

CuraTeQ Biologics Secures ANVISA Approval for Hyderabad Biosimilars Manufacturing Facility

CuraTeQ Biologics has received ANVISA GMP approval for its Hyderabad biosimilars manufacturing facility, strengthening its global regulatory credentials and enabling expanded supply of biosimilar products to Brazil and the wider Latin American market.

European Medicines Agency | 22/07/2026 | By News Bureau |  158