We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Keytruda with chemotherapy is the first anti-PD1 therapy approved in Europe for this first-line setting, said Scot Ebbinghaus, Merck’s vice president of clinical research. Read More
Actemra earned almost $3.2 billion in global sales in 2020 and the new authorization as a COVID-19 treatment should lead to a significant increase in revenue for 2021. Read More
Lilly’s antibody has already secured Breakthrough Therapy designation based on positive phase 2 trial results showing the drug slowed disease progression vs. placebo. Read More
AbbVie said Rinvoq has shown strong efficacy and a favorable benefit-risk profile, with the company pledging to continue working with the FDA on the drug’s review. Read More
Roche said it will immediately begin shipping Actemra (tocilizumab) to hospitals after receiving emergency authorization from the FDA late last week. Read More
Eli Lilly plans to pursue accelerated approval of its Alzheimer’s treatment donanemab, using the same fast-track pathway Biogen used for its controversial Alzheimer’s drug Aduhelm. Read More
The FDA deemed the data submitted for children and teens “not sufficient to obtain approval of an indication in the pediatric population at this time,” Sanofi said. Read More
The EU has approved Sanofi’s Aubagio (teriflunomide) for use in children and adolescents with multiple sclerosis — just days after the FDA issued the company a Complete Response Letter regarding its supplemental New Drug Application (sNDA) for Aubagio, rejecting its use in children and adolescents ages 10 to 17 years and requesting more pediatric data. Read More