The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming the latest organisation to quit a social media platform that some have criticised for its content.
The use of the ESMP will become mandatory for MAHs and NCAs as of Sunday, February 2. The platform is a key requirement of the European Medicines Agency’s extended mandate, enhancing shortages monitoring and preparedness across the European Union (EU)/European Economic Area (EEA).
Paracetamol, now comes with a shocking new warning: it could lead to a dangerous condition called metabolic acidosis if misused or overused.
The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...
KDEV) today announces that its portfolio company Dilafor has successfully completed regulatory meetings with the U.S. Food and Drug Administration, FDA, and European Health Agencies, regarding the continued development of the company’s drug candidate tafoxiparin.
GSK plc GSK recently announced that EMA has accepted the regulatory filing seeking approval for its IL-5 inhibitor depemokimab in two respiratory indications – asthma with type II inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP).
High-quality evidence for the treatment of very rare diseases: IQWiG is involved in the EU project RealiseD Developing clinical trials to provide good evidence for very rare diseases, so that effective treatments reach patients faster - this is the aim of the pan-European,
GSK (GSK) stock in focus as its experimental drug depemokimab undergoes EU review for asthma and nasal polyps. Read more here.
The European Medicines Agency (EMA) has decided to stop using the social media platform X due to content concerns and will instead use Bluesky. This move aligns with other organizations stepping back from X,
There are 20 cell and gene therapies on Europe's market versus 43 in the U.S. Find out more about this ecosystem.
Submission supported by positive results from global, Phase 3 4WHIM clinical trial;U.S. regulatory approval in WHIM syndrome granted in
The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance Certification Program" training has been added to ResearchAndMarkets.com's offering. This training course is designed to give pharmaceutical and biologic companies operating in the US and EU an introduction to product safety regulatory requirements.