Sanofi's Sarclisa has been an also-ran in the anti-CD38 antibody class behind Johnson & Johnson and Genmab's blockbuster Darzalex, but now has a chance to steal some of the spotlight.
Johnson & Johnson's target of $5 billion in sales for its EGFRxMET bispecific antibody Rybrevant has moved a step closer, after a new FDA approval in non-small cell lung cancer (NSCLC).
Apple has the FDA authorisation it needs to bring its software for detecting sleep apnoea to the Apple Watch, coinciding with the launch of its new operating system for the wearable.
It's known that excessive use of earbuds at high volumes can cause hearing loss, so somewhat ironic that the FDA has just authorised software that can turn Apple AirPods into hearing aids.
Emergent BioSolutions has been given FDA approval to extend the indications for its smallpox vaccine ACAM2000 to include the prevention of mpox, currently deemed a public health emergency b