FDA Grants Orphan Drug Designation to Sanofi’s Rare Disease Drug Rilzabrutinib for wAIHA & IgG4-RD
Results from Phase II studies demonstrated that rilzabrutinib showed clinically meaningful outcomes in patients with warm ...
Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in multiple sclerosisResults from the HERCULES phase 3 ...
Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in multiple sclerosis Results from the HERCULES phase 3 study showed delay in disability progression in people ...
The FDA has recently approved two new prophylactic treatments for people with hemophilia who develop antibodies to clotting ...
The FDA on Thursday gave the green light to Uplizna in IgG4-related disease, making it the first and only approved treatment ...
Zacks Investment Research on MSN4d
Pharma Stock Roundup: FDA Nod to SNY, AZN & NVS, JNJ Talc Suits FailureThis week, the FDA approved Sanofi’s SNY hemophilia therapy, fitusiran, Novartis’ NVS Vanrafia for the reduction of ...
Pharmaceutical Technology on MSN4d
FDA awards ODD status to Sanofi’s rilzabrutinib for two rare conditionsSanofi's oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor rilzabrutinib has gained US Food and Drug Administration ...
The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...
Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...
Sanofi's rilzabrutinib receives FDA orphan drug designation for two rare diseases. Clinical studies show meaningful response ...
Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...
The FDA has granted orphan drug designation to rilzabrutinib for IgG4-related disease and warm autoimmune hemolytic anemia, ...
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