The FDA granted orphan drug designation to zavabresib, an investigational therapy for the treatment of myelofibrosis, a rare ...
The RMAT designation is intended to expedite the development and evaluation of regenerative medicine therapies.
The FDA has granted breakthrough therapy designation to Novartis’ ianalumab for Sjögren’s disease, according to a press release from the manufacturer.In its statement, Novartis said it plans to submit ...
The FDA's breakthrough therapy designation facilitates accelerated development and regulatory review for therapies showing ...
January 21, 2026-- Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology th ...
Eli Lilly and Co. has received the Federal Drug Administration’s breakthrough therapy designation for a drug in development ...
The FDA has granted fast track designation to a vectorized antibody that targets RNA-binding proteins characteristic of ...
The FDA has granted breakthrough therapy designation (BTD) to soficabtagene geleucel (sofi-cel; WU-CART-007) for the ...
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