STAT15h
Sanofi is warned by the FDA over ‘significant’ problems at a key manufacturing plant
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...
ENDPOINTS NEWS17h
Sanofi says no sup­ply in­ter­rup­tions af­ter land­ing FDA warn­ing let­ter for US site
A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in ...
FiercePharma18h
Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs
Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...
FiercePharma19h
Sanofi's consumer health arm Opella secures FDA green light to pursue OTC Cialis study
After hitting a regulatory roadblock in 2022, Sanofi’s consumer healthcare business Opella has secured the FDA’s blessing to ...
Sanofi says FDA lifted clinical hold on trial for Cialis OTC switch
Sanofi’s (SNY) said FDA lifted a hold on a trial to test over-the-counter use of its Eli-Lilly (LLY)-partnered erectile ...