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
Roche has secured its first regulatory approval for mosunetuzumab, a first-in-class CD20xCD3 bispecific antibody, as a treatment for patients with follicular lymphoma (FL) in the EU.
Novartis will receive extra help from the FDA during the development of its CAR-T cancer cell therapy Kymriah for follicular lymphoma, after the regulator deemed it to be an advanced regene
US biotech Epizyme is gearing up for a potentially lucrative second indication for its Tazverik (tazemetostat), after the FDA agreed to a fast review in follicular lymphoma.
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.