Warm Autoimmune Hemolytic Anemia
Feb 10, 2026
Sanofi Advances wAIHA Program as Rilzabrutinib Receives Breakthrough and Orphan Status; Lilly Moves to Acquire Orna Therapeutics, Expanding Cell Therapy Portfolio; Roche Announces Key PPMS Trial Success for Fenebrutinib; Priovant’s Brepocitinib Demonstrates Strong Potential in Phase 2 Cutaneous Sarcoidosis Study; AstraZeneca’s DATROWAY Grants US Priority Review for 1L mTNBC Indication in Patients not Eligible for Immunotherapy
Sanofi’s Rilzabrutinib Granted Breakthrough and Orphan Designations for wAIHA Rilzabrutinib (WAYRILZ) by Sanofi (EPA: SAN) recently achieved two major regulatory milestones: FDA Breakthrough Therapy Designation in the U.S. and Orphan Drug Designation by the Japanese Ministry of Health, Labour and Welfare for the...
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Aug 20, 2020
FDA rejects BioMarin’s Valoctocogene Roxaparvovec; J&J inks $6.5B deal; Alzheon bags $47M; Research updates on diabetes
FDA rejects BioMarin's gene therapy and Gilead's filgotinib over concerns The FDA refused to approve BioMarin's hemophilia A gene therapy valoctocogene roxaparvovec. The U.S. regulator that had earlier told there was no requirement of an AdComm for the drug, aka, valrox, has issued a complete response (CRL) lett...
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Apr 06, 2020
Warm Autoimmune Hemolytic Anemia: A less prevalent disease with prevailing unmet needs
Warm Autoimmune Hemolytic Anemia market is anticipated to increase with a CAGR of 15.9% in the 7MM by 2030, estimates DelveInsight. In 2017, as per the estimates by DelveInsight, Warm Autoimmune Haemolytic Anemia had affected 82,045 people approximately in the 7MM. For a disease being tagged - rare, WAIHA affect...
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