Regulation

EC approves Pfizer’s Bavencio plus axitinib to treat advanced RCC

Pfizer and Merck KGaA announced that the European Commission (EC) has approved Bavencio (avelumab) in combination with axitinib as a first-line treatment for adult patients with advanced renal cell carcinoma (RCC).

Astellas’ gilteritinib secures EC approval to treat acute myeloid leukaemia

Astellas Pharma’s Xospata (gilteritinib) has secured approval from the European Commission (EC) as a monotherapy for the treatment of acute myeloid leukaemia (AML).

Spectrum Pharmaceuticals announces submission to FDA of updated BLA for ROLONTIS

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with a primary focus in hematology and oncology, announced today that the company submitted an updated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim).

AVROBIO receives orphan-drug designation from FDA for AVR RD 02 to treat Gaucher disease

AVROBIO announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation for the Company’s investigational gene therapy, AVR-RD-02, for the treatment of Gaucher disease.

EC approves BMS melanoma drug Opdivo two and four-week flat dosing schedule

Bristol-Myers Squibb (BMS) has secured approval from the European Commission (EC) for melanoma drug Opdivo (nivolumab) two and four-week flat dosing schedule.

FDA grants expanded approval for GSK’s ovarian cancer drug Zejula

GlaxoSmithKline (GSK) has secured expanded approval from the US Food and Drug Administration (FDA) for its Zejula (niraparib) for the late-line treatment for women with recurrent ovarian cancer.

FDA grants fast track status to Moderna’s mRNA therapeutic to treat propionic acidemia

Moderna has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational messenger RNA (mRNA) therapeutic, called mRNA-3927, to treat propionic acidemia (PA).

FDA approves TRIKAFTA to treat the underlying cause of cystic fibrosis

Vertex Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation.

Alexion receives FDA approval for ULTOMIRIS for atypical hemolytic uremic syndrome

Alexion Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved ULTOMIRIS (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) for adult and pediatric (one month of age and older) patients.