Regulation

SOLIRIS receives approval in Japan for the prevention of relapse in patients with neuromyelitis optica spectrum disorder

Alexion Pharmaceuticals announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the extension of the current marketing authorization of SOLIRIS (eculizumab) to include the prevention of relapse in patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica.

FDA approves AstraZeneca’s Calquence to treat lymphocytic cancers

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Calquence (acalabrutinib) to treat adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

EC approves two new regimens of Merck’s KEYTRUDA for metastatic or unresectable recurrent HNSCC

Merck, known as MSD outside the US and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1).

Alnylam announces approval of GIVLAARI by US FDA

Alnylam Pharmaceuticals, the leading RNAi therapeutics company, announced today that the US Food and Drug Administration (FDA) approved GIVLAARI (givosiran) injection for subcutaneous use for the treatment of adults with acute hepatic porphyria (AHP).

Newron’s sarizotan secures FDA rare paediatric status in Rett syndrome

Newron Pharmaceuticals has secured rare paediatric disease designation for sarizotan from the US Food and Drug Administration (FDA) for the treatment of Rett syndrome.

Janssen gets EC approval for Darzalex combination regimen to treat multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing authorisation from the European Commission (EC) for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DRd) to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT).

FDA approves Pfizer’s biosimilar, ABRILADA (adalimumab-afzb) for multiple inflammatory conditions

Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA (adalimumab-afzb), as a biosimilar to Humira (adalimumab), for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

Novartis’ Adakveo approved by FDA to reduce VOCs in sickle cell disease

Novartis has secured approval for Adakveo (crizanlizumab) from the US Food and Drug Administration (FDA) for its use in sickle cell disease patients.

Qtrilmet approved in EU to treat type-2 diabetes

AstraZeneca announced that the European Commission (EC) has approved Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets to improve glycaemic control in adults with type-2 diabetes (T2D).