Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)
Shots: Following the MHRA approval (Jan 2025), the EC has granted conditional MAA...
GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD
Shots: China’s NMPA has accepted the NDA for Nucala as an add-on treatm...
The US FDA Accepts NDA of Boehringer Ingelheim’s Zongertinib for HER2 (ERBB2)-Mutant NSCLC
Shots: The US FDA has accepted & granted priority review to the NDA of zongert...
Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk
Shots: The US FDA has accepted & granted priority review to the NDA of lenacap...
Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Tre...
Shots: The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblas...
Merus Receives the US FDA’s Breakthrough Therapy Designation for Petosemtamab to Treat 1L PD-L1+ Recurrent or Metastatic Head and...
Shots: The US FDA has granted BTD to petosemtamab + Keytruda as 1L treatment of r/...
