Recent regulatory developments have advanced therapeutic options in oncology and infectious diseases. The FDA has granted accelerated approval to Boehringer Ingelheim’s oral targeted therapy Zongertinib for HER2-mutated lung cancer, expanding oral targeted treatment modalities in this subset. Jazz Pharmaceuticals won FDA approval for dordaviprone (Modeyso), marking the first approved treatment for recurrent H3 K27M-mutant diffuse midline glioma, an aggressive pediatric brain cancer. Additionally, the FDA partially lifted hold and added label restrictions for Valneva’s Chikungunya vaccine, Ixchiq, following safety reviews. These approvals reflect ongoing efforts to address unmet clinical needs across diverse indications.