GlobalData on MSN4d
FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues ...
FDA Approves Sanofi's Merilog As First Rapid-Acting Insulin Biosimilar Product For Diabetes
Sanofi's Merilog wins FDA approval as the first rapid-acting insulin biosimilar to Novolog, offering a new option for diabetes management.
MM&M1d
Rx Rundown: Moderna, Sanofi, GSK and more
Millie, a modern maternity clinic, secured $12 million in Series A funding led by existing investors RH Capital, TMV, ...
BioSpace5d
Sanofi Challenges Novo With First FDA Nod for NovoLog Biosimilar
Merilog’s approval comes as the insulin space has over the past year suffered several setbacks, including strong calls for ...
FDA approves first rapid-acting insulin biosimilar for patients with diabetes
Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...
Regeneron, Sanofi Get Speedy FDA Review of Dupixent in Bullous Pemphigoid
Regeneron and Sanofi said an FDA green light would make Dupixent the first targeted medicine in the U.S. for bullous pemphigoid, a debilitating and relapsing skin disease with underlying type 2 ...
Managed Healthcare Executive3d
FDA Approves First Biosimilar of Novolog
Merilog is expected to be available in July 2025, and Sanofi will provide Merilog to patients for $35 or less for a 30-day ...
Pharm Exec5d
FDA Approves Sanofi’s Rapid Acting Insulin Biosimilar Merilog for Diabetes
The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for improving glycemic control ...
Yahoo Finance4d
FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
Sanofi and Regeneron’s blockbuster biologic ... this time for the rare autoimmune skin disorder bullous pemphigoid (BP). The US Food and Drug Administration (FDA) has accepted a supplemental ...
Regeneron, Sanofi announce Dupixent sBLA accepted for priority review by FDA
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application for ...
Sanofi treatment of autoimmune hemolytic anemia granted orphan status
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 – ...
PMLiVE3d
Sanofi and Regeneron’s Dupixent granted FDA priority review for bullous pemphigoid
Sanofi and Regeneron’s Dupixent (dupilumab) has been accepted for priority review by the US Food and Drug Administration (FDA ...