Clinical

Articles

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. 

FDA Sets PDUFA Date for Dry Eye Disease Drug

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

FDA Okays Pediatric Indication for Takeda’s Takhyzro

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 Accepts NDA for Zuranolone for Depression

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

FDA Warns Companies Claiming to Treat Monkeypox

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

FDA Approves Trodelvy for HR+/HER2- Breast Cancer

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

FDA Approves Tezspire in Pre-Filled Pen

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

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.

FDA Approves Novel Therapy for CKD-Related Anemia

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.

FDA Approves Orserdu to Treat Metastatic Breast Cancer

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.

FDA Approves Lilly’s BTK Inhibitor for Rare Blood Cancer

This approval marks the fifth indication for Keytruda-based regimens in non-small cell lung cancer and the 34th indication in the United States.

Regulatory Updates