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© 2021 MJH Life Sciences and Formulary Watch. All rights reserved.
© 2021 MJH Life Sciences™ and Formulary Watch. All rights reserved.
September 23, 2021
This is the fourth approval for Jakafi, a JAK1/JAK2 inhibitor.
People over the age 65 and those at high risk of severe COVID-19, including health care workers and those with occupational exposure, are eligible for the booster.
September 22, 2021
Dr. Reddy’s has also launched a generic of Librax. Recent generic approvals include clindamycin phosphate foam and sodium acetate.
Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.
Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.
September 21, 2021
The FDA assigned a PDUFA action date of March 20, 2022, for ganaxolone.
In trials, Skyrizi demonstrated improvements in clinical remission and endoscopic response as both induction and maintenance therapy
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.
September 20, 2021
Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.
The approval comes more than two months ahead of its PDUFA target date of December 4, 2021.