Shots:The US FDA has accepted sNDA & granted priority review to leniolisib for the treatment of children (4-11yrs.) with activated phosphoinositide 3-kinase delta (APKD) syndrome (PDUFA: Jan 31, 2026); regulatory review is ongoing in the EEA, Japan & CanadasNDA was supported by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced…
Shots:The US FDA approved 6 NDAs and 1 BLA in March 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 26 novel products in 2023In March 2023, the major highlights drugs were, Tafinlar + Mekinist approval for BRAF V600E low-grade glioma, Zynyz for metastatic or…

