FDA Okays Pediatric Indication for Takeda’s Takhyzro

February 6th 2023

Takhyzro is the first therapy to prevent attacks of hereditary angioedema (HAE) in children ages to 2 to under 6.

FDA Accepts NDA for Zuranolone for Depression

February 6th 2023

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.

FDA Warns Companies Claiming to Treat Monkeypox

February 4th 2023

The products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis.

FDA Approves Trodelvy for HR+/HER2- Breast Cancer

February 3rd 2023

Trodelvy has been recommended as a preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network.

FDA Approves Tezspire in Pre-Filled Pen

February 3rd 2023

Tezspire is a biologic that specifically targets the inflammation associated with asthma.