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© 2023 MJH Life Sciences and Formulary Watch. All rights reserved.
© 2023 MJH Life Sciences™ and Formulary Watch. All rights reserved.
February 07, 2023
If approved, reproxalap would be the first inhibitor of RASP to treat patients with dry eye disease. The FDA PDUFA date is Nov. 23, 2023.
February 06, 2023
Takhyzro is the first therapy to prevent attacks of hereditary angioedema (HAE) in children ages 2 to under 6.
Zuranolone is a rapid-acting neuroactive steroid that can take effect in 14 days to treat patients with major depressive disorder and postpartum depression. The FDA has assigned a PDUFA action date of Aug. 5, 2023.
February 04, 2023
The products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis.
February 03, 2023
Trodelvy has been recommended as a preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network.
Tezspire is a biologic that specifically targets the inflammation associated with asthma.
February 02, 2023
Daprodustat, now with the brand name of Jesduvroq, is a new oral therapy but it carries a boxed warning about the risk of cardiovascular events.
January 30, 2023
Elacestrant, now with the brand name Orserdu, is an oral selective estrogen receptor degrader (SERD), which works by blocking the effects of estrogen on hormone receptor-positive breast cancer cells.
January 27, 2023
Jaypirca is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor. It has a wholesale acquisition cost of $21,000 per 30 days of therapy.
This approval marks the fifth indication for Keytruda-based regimens in non-small cell lung cancer and the 34th indication in the United States.