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© 2021 MJH Life Sciences and Formulary Watch. All rights reserved.
© 2021 MJH Life Sciences™ and Formulary Watch. All rights reserved.
The therapy, a recombinant version, was developed to address supply and manufacturing issues.
July 08, 2021
The prescribing information for Aduhelm now specifies its use in patients with a mild form of the disease.
The agency also granted tezepelumab priority review with a PDUFA date sometime in the first quarter of 2022.
July 07, 2021
The company is transferring manufacturing of the final product to its own site in Austria.
July 06, 2021
Despite an advisory committee recommendation for approval, the FDA did not approve what would have been the first disease-modifying therapy for type 1 diabetes.
This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.
July 02, 2021
The move follows an April 29 vote by the FDA Oncology Drugs Advisory Committee.
July 01, 2021
June 29, 2021
The label for the type 2 diabetes treatment has been updated to include the risk of ketoacidosis and damage to the kidney.
June 28, 2021
Kite plans to submit a supplemental BLA based on these findings.
The authorization is based on four studies that evaluated Actemra in more than 5,500 hospitalized patients.