Johnson & Johnson’s Invokana has fallen behind SGLT2 rivals over amputation fears, but success in the Credence renal trial, profiled at the International Society of…
Astrazeneca gets one over on Sanofi and Lexicon with European approval for Forxiga. US regulators might not be so forgiving.
Others hoping to get FDA approvals include Sage Therapeutics and Novartis, but hopes look dimmer for Lexicon and Sanofi.
US approval of Lexicon and Sanofi’s SGLT inhibitor in type 1 diabetes hangs in the balance after an adcom tie.
No slowdown at the FDA, as regulator remains on track to approve at least 43 new drugs this year.