Zacks Investment Research on MSN1d
EMA Accepts GSK's Filing for Expanded Use of Nucala in COPD
GSK plc GSK announced that the European Medicines Agency (“EMA”) has accepted for review a regulatory filing, seeking ...
Pharmaceutical Technology on MSN18h
EMA to review GSK’s Nucala for COPD treatment expansion
The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on ...
GlobalData on MSN11d
Unsafe and unregulated cell therapies being sold in Europe
The European Medicines Agency (EMA) has issued a warning about the dangers of unregulated advanced therapy medicinal products ...
NL Times4d
European Medicines Agency gives first green light to AI use citing liver biopsy trial
The European Medicines Agency (EMA) gave its approval to an artificial intelligence diagnostic tool for the first time on ...
Euractiv1d
Pharma industry wants streamlined EU medical device rules
To avoid overlaps, the industry is calling for aligning MDR/IVDR with the EU's digital frameworks, pharmaceutical regulations ...
The Pharma Letter11d
EMA annual report 2024
At its March meeting, the European Medicines Agency’s management board adopted the EMA’s annual report for 2024. This ...
Can-Fite Initiates Pivotal Phase 3 Psoriasis Study of its Oral Drug Piclidenoson with FDA & EMA-Approved Protocol
The psoriasis market is estimated at $30 Billion by 2030 and has shifted significantly to oral drugs Ramat Gan, Israel, March ...
PathAI Announces EMA Qualification for AIM-MASH AI Assist, a Groundbreaking AI Tool for MASH Clinical Trials
PathAI, a global leader in AI-powered pathology, today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted full qualification for ...
EMA accepts GSK's application to expand Nucala use
GSK said on Monday that the European Medicines Agency has accepted its application to expand the use of ‘Nucala’, or ...
The American Journal of Managed Care12d
Uniform Global Standards, Processes Could Accelerate CGT Approvals, Access
The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
CStone Submits Application to the European Medicines Agency for New Indication of Sugemalimab in Stage III Non-Small Cell Lung Cancer
CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Type II variation application to the ...