Plixorafenib breakthrough status raises the stakes for FORE Biotherapeutics in BRAF-mutant high-grade glioma
FORE Biotherapeutics won FDA breakthrough status for plixorafenib in high-grade glioma. Read what this changes and what risks still remain.
No FDA advisory committee for MOLBREEVI: what Savara’s Day 74 Letter means for the August PDUFA review
Savara’s molgramostim BLA faces no FDA adcom. Analysis of what the August 2026 PDUFA date means for autoimmune PAP treatment access. Read more.
Relay Therapeutics secures FDA breakthrough designation for zovegalisib in PIK3CA-mutant HR+/HER2- advanced breast cancer
FDA grants breakthrough therapy designation to Relay Therapeutics’ zovegalisib. Find out what this changes for PI3K-mutant breast cancer treatment.