EU unveils draft guidance to fast-track clinical trials during public health emergencies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

Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints

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

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

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

Novartis’ remibrutinib bags positive CHMP opinion for chronic urticaria

The oral therapy is aimed at adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines

EU to withdraw Levamisole medicines over risk of rare, deadly brain disorder

The recommendation is based on new data from continuous safety monitoring of medicines in the EU

Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe

STADA & Bio-Thera bag European nod for Gotenfia

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors