Sanofi gets FDA untitled letter over Beyfortus promotional emails
The FDA has called out Sanofi’s promotion of respiratory syncytial virus (RSV) antibody Beyfortus in a new untitled…
FDA approves Sanofi drug delivered with Enable on-body device
Enable Injections’ on-body delivery device [Photo courtesy of Enable Injections]Sanofi announced today that the FDA approved the delivery…
Sanofi asks out of CNPV fast-track program for Tzield expansion
Since it was established nearly a year ago by the FDA, the Commissioner’s National Priority Voucher (CNPV) program…
After a 2-month delay, Sanofi gains FDA expansion of Tzield
After accepting Sanofi’s application for an expansion of its Type 1 diabetes treatment Tzield and putting it in…
Sanofi Wins FDA Nod for Expanded Use of T1D Drug in Children
Sanofi SNY announced that the FDA has approved its type I diabetes (T1D) drug, Tzield (teplizumab), for a…
FDA approves Sanofi diabetes drug for children with stage 3 diabetes
Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the…
Drug Regulation and Innovation: How Sanofi Collaborates with the FDA
Once an expedited pathway is granted, the therapeutics dossier – a thorough collection of documents submitted to the…
Sanofi seeks to pull drug from Makary FDA speedy review program
Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the…