The European Medicines Agency (EMA) has recommended ten new products for approval at a bumper June meeting which also saw therapeutic extensions granted for eleven drugs. The watchdog’s… read more.
Vaccine manufacturers have been tasked with producing vaccines that protect against three influenza viruses, as Europe gears up for another flu season. Companies are actively producing millions of… read more.
Real-world data looks set to play an increasingly important role in how medicines are assessed for safety and effectiveness in Europe. The Data Analysis and Real-World Interrogation Network… read more.
The European Medicines Agency (EMA) has recommended the approval of twelve new products, following reviews by its key human medicines committee (CHMP). This brings to twenty-five the number… read more.
The winter flu season may be over in the northern hemisphere, but EU regulators are already looking ahead to the next outbreak in autumn 2024. Influenza viruses continuously… read more.
There are stark differences between European countries when it comes to both the reimbursement of, and access to, new treatments for patients with early-stage lung cancer. There are… read more.
SpringWorks Therapeutics, Inc. announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of… read more.
The European Medicines Agency, the EU drug watchdog, has approved the first medicine using CRISPR/Cas9, a novel gene-editing technology. Casgevy (exagamglogene autotemcel) is indicated for the treatment of… read more.
Artificial intelligence (AI) will play a role in drug development, including the way in which medicines are regulated, according to European experts. The European Medicines Agency (EMA) and… read more.
The European Medicines Agency (EMA) has recommended seven medicines for approval at its October 2023 meeting. The brings the total number of newly approved medicines this year to… read more.
The European Medicines Agency (EMA) has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The changes give access… read more.
The European Medicines Agency (EMA) is warning patients and healthcare professionals to beware of pre-filled pens falsely labelled as Ozempic, a diabetes medicine linked to weight loss. National… read more.
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