Four drugs or medical devices approved by the FDA since June 7:
1. Polivy, novel antibody drug conjugate, was approved in combination with chemotherapy, for patients with relapsed or refractory diffuse large B-cell lymphoma.
2. IB-Stim is a prescription-only device for the relief of pain associated with irritable bowel syndrome in patients between the ages of 11 and 18. It is the first medical device approved for adolescents experiencing IBS.
3. Keytruda, Merck's blockbuster cancer drug, was approved by the FDA to treat a type of head and neck cancer called squamous cell carcinoma. It was approved for use as monotherapy, as well as in combination with a chemotherapy regimen.
4. Kanjinti, manufactured by Amgen and Allergan, is a biosimilar to Herceptin, which treats HER2-positive metastatic breast cancer and HER2-positive gastric cancer.