Regeneron Pharmaceuticals and Sanofi announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Trazimera (trastuzumab-qyyp), an oncology biosimilar to Genentech’s Herceptin (trastuzumab).
The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the US Food and Drug Administration (FDA) for its Spravato (esketamine) CIII nasal spray for adults with treatment-resistant depression (TRD).
Roche announced that the US Food and Drug Administration (FDA) has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection to treat certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease.
AstraZeneca has secured expanded approval from the US Food and Drug Administration (FDA) for Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin HCl extended-release) to treat type 2 diabetes (T2D) and moderate renal impairment.
Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda (pembrolizumab) as the adjuvant treatment for patients with melanoma with involvement of lymph node(s) following complete resection.
Pfizer announced that the European Commission (EC) has approved ZIRABEV for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix.
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Egaten (triclabendazole) to treat fascioliasis in patients six years of age and older.
Finch Therapeutics Group has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug CP101 to treat patients with recurrent Clostridium difficile (C. difficile) infection.
Sanofi has secured approval from the US Food and Drug Administration (FDA) for its blood-disorder drug Cablivi (caplacizumab-yhdp).
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