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The FDA has granted a Priority Review to AstraZeneca and Amgen’s investigational asthma treatment tezepelumab — setting a target decision date for the Biologics License Application (BLA) in the first quarter of 2022. Read More
Merck said it made the voluntary decision in consultation with the FDA following the evaluation of the application by the agency’s Oncologic Drugs Advisory Committee. Read More
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