Azercabtagene zapreleucel has been granted fast track designation from the FDA for the treatment of diffuse large B-cell ...
The developer of a spray-based erectile dysfunctional treatment, LTR Pharma has found a pre-approval route to the US market.
FDA grants fast track designation to azer-cel, an allogeneic CAR T-cell therapy, for relapsed or refractory diffuse large ...
FDA has granted CLPH-511 Fast Track Designation for the treatment of acute hemorrhage as an alternative to conventional ...
The FDA has granted fast-track designation to nipocalimab for the treatment of Sjögren’s disease, according to a press ...
The Food and Drug Administration has granted Fast Track designation to LTG-001 for the treatment of acute pain.
The FDA granted fast track designation to ATSN-201 for the treatment of X-linked retinoschisis, according to a press release ...
Sungen Biomedical's world-first new drug SGC001 monoclonal antibody receives FDA fast track approval
On , US time, the world's first acute myocardial infarction (AMI) antibody drug, SGC001, developed by Sungen Biomedical-an innovative biopharmaceutical company incubated by Beijing Hotgen Biotech Co., ...
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Atsena’s ATSN-201 gains FDA fast track status for XLRS treatmentAtsena Therapeutics has received fast track designation from the FDA for ATSN-201, aimed at treating X-linked retinoschisis ...
Johnson & Johnson's nipocalimab receives FDA Fast Track status for Sjögren's disease, following strong Phase 2 trial results on disease activity and IgG reduction.
The Food and Drug Administration (FDA) has granted Fast Track designation to STM-01 for the treatment of heart failure with preserved ejection fraction ...
Fred Aslan, MD, CEO, Artiva Biotherapeutics, explains what the FDA Fast Track designation for AlloNK in autoimmune diseases means for the acceleration of its development and potential approval of the ...
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