sanofi
2 stories tagged "sanofi"
Investigations
One Irish Plant Releases Both of Sanofi's Pompe Enzymes. In June, the FDA Called Its Drugs 'Adulterated.'
One Irish plant runs the final release for both of Sanofi's lifelong Pompe enzymes. It just failed an FDA inspection on that exact step, and now the company says the fix could take months while patients confirm their next shipments.
Drugs & FDAThe $200K Pediatric Diabetes Shot Just Won a Bigger Label. The Number That Won Isn't the One Families Will Ever See.
The FDA gave Tzield an accelerated nod for kids 8 to 17 newly diagnosed with Stage 3 type 1 diabetes. The C-peptide number won. The endpoints families would actually feel did not.