The FDA has granted a priority review to Roche's T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the drug by 29 December.
The FDA's decision not to approve Spero Therapeutics' oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic re
Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA's Vaccines and Related Biological Produc
Gilead Sciences has refiled for FDA approval of its HIV capsid inhibitor lenacapavir – which only needs to be dosed every six months – after the drug was rejected by the regulator in Februa
Sanofi has claimed approval in the EU for Xenpozyme as a treatment for acid sphingomyelinase deficiency (ASMD) – which becomes the first and only treatment option for patients with the rare
Basilea Pharmaceutica may finally be able to bring its antibiotic ceftobiprole to the US market – 13 years after its first attempt was turned down – thanks to a new phase 3 clinical trial.<
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.