An oncology biosimilar, a women’s libido drug & 3 more FDA approvals

Five drugs or medical devices approved by the FDA since June 21:

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1. Zirabev, manufactured by Pfizer, is a biosimilar to Avastin, a treatment for metastatic colorectal cancer, metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and metastatic cervical cancer.

2. Soliris, an injection, was approved for the treatment of neuromyelitis optica spectrum disorder, a rare autoimmune disease affecting the central nervous system. 

3. Dupixent is the first treatment approved for chronic rhinosinusitis with nasal polyps, which are growths on the inner lining of sinuses. 

4. Vyleesi, an under-the-skin injection, is a treatment for premenopausal women with hypoactive sexual desire disorder. It is intended to increase desire in women who experience “low sexual desire that causes marked distress or interpersonal difficulty.”

5. The FDA expanded approval of Symdeko, tablets that treat cystic fibrosis, to include patients ages 6 years and older. Symdeko was previously approved for use in patients ages 12 and older. 

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