Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency

The accelerated review covers WCK 5222 for multiple critical infections

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union

NovoSeven recommended for approval for the treatment of severe postpartum haemorrhage by the European Medicines Agency

Heavy bleeding after giving birth is globally a leading cause of death in new mothers

EU nod to Rezurock for chronic GVHD in adults & teens

Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation

EMA moves to cut animal testing with “virtual control groups” in preclinical research

The approach, which could significantly reduce the number of rats used in certain dose-range finding studies

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

GSK seeks European nod for promising Hepatitis B therapy

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

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