News about "European Medicines Agency (EMA"

Formycon and OneSource Partner to Manufacture Biosimilars

Formycon and OneSource Specialty Pharma have partnered to manufacture biosimilars, with OneSource providing integrated Drug Substance (DS) and Drug Product (DP) manufacturing from its Bengaluru biologics facility.

European Medicines Agency (EMA) | 15/07/2026 | By News Bureau

EMA Fast-Tracks Review of New Metastatic Pancreatic Cancer Drug

The European Medicines Agency (EMA) has initiated a phased review of a new medicine for metastatic pancreatic cancer, accelerating its assessment to address a significant unmet medical need.

European Medicines Agency (EMA) | 09/07/2026 | By News Bureau

Lupin Secures EMA Approval for Expanded NaMuscla Pediatric Use

Lupin has received EMA approval to expand the pediatric indication of NaMuscla, including two new capsule strengths of 62 mg and 83 mg.

European Medicines Agency (EMA) | 03/07/2026 | By News Bureau |  323

CHMP Recommends Lilly's Jaypirca for CLL Treatment in EU

CHMP has recommended Lilly’s Jaypirca (pirtobrutinib) for EU approval in adults with chronic lymphocytic leukemia (CLL), potentially expanding its use across all lines of therapy.

European Medicines Agency (EMA) | 29/06/2026 | By News Bureau

US FDA and EMA Accept Cemdisiran Regulatory Submissions for Generalised Myasthenia Gravis

The FDA and EMA have accepted regulatory submissions for cemdisiran to treat generalised Myasthenia Gravis (gMG). If approved, it could become the first siRNA therapy for gMG with convenient quarterly subcutaneous dosing.

European Medicines Agency (EMA) | 25/06/2026 | By News Bureau |  113

WuXi Biologics Secures 4th EMA GMP Certification for Suzhou Facility

WuXi Biologics’ Suzhou Biosafety Testing Center has received its 4th EMA GMP certification, supporting European Union (EU) Marketing Authorisation (MA) applications for 19 biologics from 13 stakeholders.

European Medicines Agency (EMA) | 18/06/2026 | By News Bureau

Zai Lab Secures EMA Orphan Drug Status for Zoci in Pulmonary Neuroendocrine Carcinomas

Zai Lab has received EMA Orphan Drug Designation (ODD) for zocilurtatug pelitecan (zoci) in pulmonary neuroendocrine carcinomas. The designation recognises promising clinical data suggesting potential benefits over existing therapies for patients with relapsed or refractory extensive-stage Small Cell Lung Cancer (SCLC).

European Medicines Agency (EMA) | 17/06/2026 | By News Bureau

EMA Confirms Asundexian MAA for Assessment in Secondary Prevention of Ischemic Stroke

The EMA has accepted the Marketing Authorisation Application (MAA) for asundexian, the first Factor XIa (FXIa) inhibitor under review in Europe for secondary prevention of ischemic stroke. The submission is supported by positive phase 3 OCEANIC-STROKE data.

European Medicines Agency (EMA) | 11/06/2026 | By News Bureau |  158

EMA Recommends Approval of Jascayd for IPF and Progressive Pulmonary Fibrosis

Jascayd receives positive CHMP recommendation for approval in Europe to treat Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), addressing major unmet needs in severe and life-threatening lung diseases.

European Medicines Agency (EMA) | 25/05/2026 | By News Bureau |  157

US FDA Approves Wegovy by Novo Nordisk as first Oral GLP-1 for Weight Loss

Wegovy’s approval is supported by phase III OASIS 4 trial data showing a mean weight loss of 16.6 percent, with the oral GLP-1 indicated for long-term weight management and reduction of major adverse cardiovascular events, and Novo Nordisk planning a US launch in early January 2026.

European Medicines Agency (EMA) | 23/12/2025 | By News Bureau |  329