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
The FDA has extended the emergency use authorisation for Gilead Sciences' antiviral Veklury to include non-hospitalised patients with COVID-19, extending the uses of the drug.
After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics.
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.