It's official – President Joe Biden's choice for FDA commissioner, Robert Califf, has been confirmed to the role after a narrow 50 to 46 vote in the Senate that relied on crossover Republic
FDA advisors have voted against approval of Eli Lilly and Innovent Biologics' cancer immunotherapy sintilimab, undermining hopes of a new, lower-priced option in the PD-1/PD-L1 inhibitor cl
The FDA has dropped a bomb on Eli Lilly's marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday.
Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US.
Robert Califf has made a series of commitments to try to win over senators reluctant to back his nomination as the next FDA commissioner, ahead of the deciding vote on his appointment.
The FDA has issued a complete response letter (CRL) to Merck & Co's gefapixant candidate for refractory chronic cough, delaying the programme and giving Bayer an opportunity to close th