The Lupus Research Alliance applauds the decision by the U.S. Food and Drug Administration (FDA) to grant Breakthrough Therapy designation for litifilimab (BIIB059) in clinical development by Biogen ...
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 US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis’ ianalumab for Sjögren’s ...
- Data from the DELIVER registrational expansion cohort is expected in late 2025, with a potential BLA submission for U.S. accelerated approval anticipated in early 2026 - WALTHAM, Mass., Aug. 04, ...
DENVER, April 08, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients ...
NXC-201 is currently the only therapy in active development for relapsed/refractory AL Amyloidosis to receive this FDA designation, according to the company. AL Amyloidosis is a rare disease with no ...
HONG KONG, Nov. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) announced that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for ...
China NMPA grants breakthrough therapy designation to Kelun-Biotech’s sacituzumab tirumotecan in combo with immunotherapy pembrolizumab for first-line treatment of PD-L1-positive NSCLC ...
Designation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1Distinction expedites development and review of treatments for serious ...
Pharmaceutical Technology on MSN
FDA grants Novartis’ ianalumab breakthrough therapy status for Sjögren’s disease
Novartis intends to submit ianalumab for regulatory approval globally in early 2026.
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