Bavarian Nordic seeks EMA nod for Mpox vaccine in children aged 2–11
The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN
The trial demonstrated that immune responses in children were non-inferior to adults, with a similar safety profile after two standard doses of MVA-BN
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
Price of the starting dose of Ozempic and Wegovy reduced by 36% and 48% respectively
The Macau authorization followed a regulatory review that considered prior decisions by both the US FDA) and the European Medicines Agency
The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
The decision marks a pivotal moment for the Massachusetts-based biotech giant
KEYTRUDA had previously met its primary endpoint of progression-free survival in all patients
AA, a chronic immune disease, can cause extensive and unpredictable hair loss
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