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FDA Grants Breakthrough Therapy Designation to Merck, Daiichi Sankyo’s R-DXd for Platinum-Resistant Ovarian Cancer

R-DXd has previously shown promising clinical results in platinum-resistant ovarian, peritoneal, and fallopian tube cancers.

MRK, Daiichi's ADC Drug Gets FDA Breakthrough Tag for Ovarian Cancer

Merck (MRK) and its Japanese partner Daiichi Sankyo announced that the FDA has granted Breakthrough Therapy Designation ("BTD") to their investigational pipeline candidate, raludotatug deruxtecan ...

Corbus higher as FDA issues another fast track tag for lead asset

Corbus Pharma (CRBP) stock rises as the company gains a new Fast Track designation for its lead drug, CRB-701 in head and neck cancer. Read more here.

IONS Up on FDA's Breakthrough Tag for ION582 in Angelman Syndrome

Ionis Pharmaceuticals IONS announced that the FDA has granted the Breakthrough Therapy designation to its pipeline candidate, ION582, for the treatment of Angelman syndrome (AS), a rare neurological ...

RCKT Stock Up on FDA's RMAT Tag to Gene Therapy for Heart Failure

Rocket Pharmaceuticals RCKT announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational adeno-associated virus (AAV)-based gene therapy, ...

SNY's Gene Therapy Candidate for Eye Disease Gets FDA Fast Track Tag

Sanofi SNY announced that the FDA granted fast track designation to its investigational gene therapy, SAR402663, for the treatment of neovascular (or wet) age-related macular degeneration (AMD). How ...

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