Approvals

FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers

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 gets FDA expanded approval for Farxiga and Xigduo XR

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 gets FDA nod for Keytruda as adjuvant treatment for melanoma

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 secures approval from European Commission for Avastin biosimilar

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.

FDA approves Novartis’ Egaten to treat fascioliasis

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 gets FDA breakthrough therapy status for CP101 to treat recurrent C. Difficile infection

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 gets FDA nod for blood disorder drug Cablivi

Sanofi has secured approval from the US Food and Drug Administration (FDA) for its blood-disorder drug Cablivi (caplacizumab-yhdp).

Merck’s 15-valent pneumococcal conjugate vaccine gets FDA breakthrough therapy designation

Merck has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its V114 investigational 15-valent pneumococcal conjugate vaccine.

FDA approves Imbruvica combo for treatment-naive CLL patients

Johnson & Johnson (J&J) and AbbVie have secured approval from the US Food and Drug Administration (FDA) for Imbruvica plus obinutuzumab as non-chemotherapy combination regimen for treatment- naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).