News | January 01, 2026
Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency
The accelerated review covers WCK 5222 for multiple critical infections
The accelerated review covers WCK 5222 for multiple critical infections
Decision on EU marketing authorisation for this population expected by September 2024
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
Heavy bleeding after giving birth is globally a leading cause of death in new mothers
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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