Regulation - Approvals

Genentech gets FDA nod for Tecentriq plus chemotherapy to treat ES-SCLC

Roche Group member Genentech has secured approval from the US Food and Drug Administration (FDA) for its Tecentriq (atezolizumab) in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

European Commission approves Roche’s MabThera for rare autoimmune disease

Roche have announced that the European Commission (EC) has approved MabThera (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes.

FDA approves Dupixent for moderate-to-severe atopic dermatitis in adolescents

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 gets FDA approval for oncology biosimilar Trazimera

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).

FDA approves Janssen’s Spravato CIII nasal spray to treat depression

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).

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.