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).
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.
Roche announced that the European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors.
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).
Sanofi has secured priority review from the US Food and Drug Administration (FDA) for its human monoclonal antibody Dupixent (dupilumab) as an add-on maintenance treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP).
Roche has secured marketing authorization from the European Commission (EC) for its Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy for initial treatment of people with a specific type of metastatic lung cancer.
The National Institute for Health and Care Excellence (NICE) in the UK is seeking additional data on Amgen’s Blincyto (blinatumomab) to treat adults with acute lymphoblastic leukaemia (ALL).
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).
Celgene announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for fedratinib and granted a Priority Review.
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