Skip to content Skip to footer

TOLREMO Therapeutics’ TT125-802 Secures 2 US FDA’s Fast-Track Designation for NSCLC with EGFR & KRAS-G12C Mutation

Shots: The US FDA has granted 2 FTDs to TT125-802 for NSCLC: one for EGFR exon 19 deletion or exon 21 L858R mutation pts progressing after EGFR inhibitors, & another for KRAS G12C-mutated pts progressing after KRAS G12C inhibitors TT125-802 is being assessed in P-I trial to evaluate its safety, tolerability, PK, & efficacy in…

Read more

New Drug Designations - November 2023

New Drug Designations – November 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices  Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…

Read more