US FDA grants Breakthrough Therapy Designation to Pfizer’s Respiratory Syncytial Virus vaccine…
The decision is primarily informed by the positive results of a proof-of-concept, phase IIa study evaluating the safety,…
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Breakthrough Therapy Designation
US FDA grants breakthrough therapy designation to Roche’s anti-amyloid beta antibody gantenerumab
Gantenerumab is an investigational antibody in phase-III development for early Alzheimer's disease (AD)
FDA grants BTD for Venclexta in combination with azacitidine to treat patients with myelodysplastic…
Every year, approximately 10,000 people are diagnosed with myelodysplastic syndromes (MDS) in the US, and there remains a high…
Junshi Biosciences gets US FDA Breakthrough Therapy Designation for Toripalimab to treat…
It is the first anti-PD-1 antibody from China to receive BTD
US FDA grants Breakthrough Therapy Designation for Takeda’s Pevonedistat
The investigational drug is for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS)