As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...

HHS secretary RFK Jr. said that he would “shut the revolving door to reestablish public trust” in the department.

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 – ...

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 ...

Cavazzoni stepped down from her role as head of the FDA’s main drug review office in mid-January. She will succeed Aida ...

Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the ...

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 ...