Breakthrough Therapy Designation
Bayer Receives Breakthrough Therapy Designation in US and China for Sevabertinib in First-Line HER2-Mutant NSCLC
Bayer; sevabertinib; Breakthrough Therapy Designation; HER2-mutant NSCLC; FDA; China CDE; first-line treatment
Updated Efficacy Data of Ivonescimab Plus Chemotherapy as First-Line Treatment for TNBC at ESMO IO 2025
ivonescimab; Yidafan; PD-1/VEGF bispecific antibody; triple-negative breast cancer; TNBC; first-line treatment; ESMO IO 2025; Phase II trial; chemotherapy combination; objective response rate; progression-free survival; disease control rate; PD-L1 CPS subgroups; safety profile; Breakthrough Therapy Designation; HARMONi-BC1; AK112-308
Merck to Acquire Cidara Therapeutics for $9.2 Billion
Merck; Cidara Therapeutics; acquisition; $9.2 billion; CD388; influenza prevention; antiviral; drug-Fc conjugate; Breakthrough Therapy Designation; Keytruda
Dyne Therapeutics Reports Positive Results for Duchenne Drug DYNE-251, Plans FDA Approval Submission
Dyne Therapeutics; DYNE-251; Duchenne muscular dystrophy; exon 51 skipping; DELIVER trial; FDA Breakthrough Therapy Designation; Biologics License Application; accelerated approval