Merck’s Keytruda secures FDA approval for advanced cervical cancer
The approval has been given for treatment of patients whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. Merck said that the
The US Food and Drug Administration (FDA) has granted rare paediatric disease designation to Vanda Pharmaceuticals’ VCA-894A, an investigational antisense oligonucleotide therapy for Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S).
In addition, BridgeBio announced that it was launching a new subsidiary, Origin Biosciences, with sufficient capital to support clinical development of ALXN1101 through potential regulatory approval and commercialization.
Tagrisso is a third-generation and irreversible EGFR-TKI designed to suppress both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. The approval was based on data