Bayer Reports the US FDA’s sBLA Acceptance of Nubeqa (Darolutamide) to Treat Metastatic Hormone-Sensitive Prostate Cancer
Shots: The US FDA has accepted for review the sBLA of Nubeqa plus androgen depriva...
GSK’s Arexvy Vaccine Receives the MHLW’s Approval for its Expanded Age Indication to Prevent RSV Disease
Shots: The Japanese MHLW has granted approval to GSK's Arexvy RSV vaccine for...
InxMed’s Ifebemtinib Secures the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of KRAS G12C Mutated NSCLC
Shots: The NMPA has granted BTD to ifebemtinib (IN10018) plus garsorasib as a 1L t...
Nurix Therapeutics’ NX-5948 Secures the EMA’s PRIME Designation for Treating R/R Chronic Lymphocytic Leukemia
Shots: The EMA has granted PRIME designation to NX-5948 for adults with r/r chroni...
UCB’s Bimzelx (Bimekizumab-bkzx) Secures the US FDA’s Approval for Treating Moderate to Severe Hidradenitis Suppurativa (HS)
Shots: The US FDA has granted approval to Bimzelx (IL-17F & IL-17A inhibitor)...
Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary...
Shots: The US FDA’s accelerated approval of Ziihera (50mg/mL, IV) was based...
