An FDA vaccine advisory committee meeting to discuss next season’s flu vaccine has been canceled, potentially delaying the ...
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GlobalData on MSNFDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoidSanofi and Regeneron’s blockbuster biologic Dupixent (dupilumab) is poised for yet another label expansion, this time for the ...
The FDA’s abrupt decision to cancel next month’s vaccine advisory committee meeting is raising concerns about whether the U.S ...
Each year, flu vaccines are tailored to match the most prevalent virus strains expected to circulate. Without an official ...
The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for improving glycemic control ...
Merilog’s approval comes as the insulin space has over the past year suffered several setbacks, including strong calls for ...
The U.S. Food and Drug Administration approved Merilog as biosimilar to Novolog for the improvement of glycemic control in adults and pediatric ...
The FDA granted orphan designation to Sanofi ( SNY) US Services’ rilzabrutinib as a treatment of autoimmune hemolytic anemia, according to a post to the agency’s website. Published first on TheFly – ...
Sanofi and Regeneron’s blockbuster biologic ... The US Food and Drug Administration (FDA) has accepted a supplemental biologics licence application (sBLA) for priority review, with a decision ...
Sanofi's Merilog wins FDA approval as the first rapid-acting insulin biosimilar to Novolog, offering a new option for diabetes management.
Sanofi and Regeneron’s Dupixent (dupilumab) has been accepted for priority review by the US Food and Drug Administration (FDA ...
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