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Results For "European-Medicines-Agency"

242 News Found

Bavarian Nordic seeks EMA nod for Mpox vaccine in children aged 2–11
Drug Approval | March 31, 2026

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


Teva hits major biosimilar milestones with FDA nod and regulatory filings
Drug Approval | March 31, 2026

Teva hits major biosimilar milestones with FDA nod and regulatory filings

The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia


Novo Nordisk India sets patient-centred price of Rs. 202/day for starting dose of Ozempic and Wegovy
News | March 31, 2026

Novo Nordisk India sets patient-centred price of Rs. 202/day for starting dose of Ozempic and Wegovy

Price of the starting dose of Ozempic and Wegovy reduced by 36% and 48% respectively


ImmunityBio scores first Asian approval for ANKTIVA in Macau
News | March 25, 2026

ImmunityBio scores first Asian approval for ANKTIVA in Macau

The Macau authorization followed a regulatory review that considered prior decisions by both the US FDA) and the European Medicines Agency


EU unveils draft guidance to fast-track clinical trials during public health emergencies
Policy | March 09, 2026

EU unveils draft guidance to fast-track clinical trials during public health emergencies

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


Roche’s Gazyva shows breakthrough results in Lupus phase III trial
Clinical Trials | March 07, 2026

Roche’s Gazyva shows breakthrough results in Lupus phase III trial

Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints


Moderna wins EU backing for world’s first combined flu-COVID shot
News | March 02, 2026

Moderna wins EU backing for world’s first combined flu-COVID shot

The decision marks a pivotal moment for the Massachusetts-based biotech giant


Merck’s KEYTRUDA shows significant survival boost in platinum-resistant ovarian cancer
Clinical Trials | February 28, 2026

Merck’s KEYTRUDA shows significant survival boost in platinum-resistant ovarian cancer

KEYTRUDA had previously met its primary endpoint of progression-free survival in all patients


Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe
News | February 28, 2026

Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe

AA, a chronic immune disease, can cause extensive and unpredictable hair loss