Roche announced that the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) for satralizumab for the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (NMOSD), granting it Accelerated Assessment.
Terns Pharmaceuticals has secured fast track designation from the US Food and Drug Administration (FDA) for its TERN-101 investigational farnesoid X receptor (FXR) agonist to treat non-alcoholic steatohepatitis (NASH).
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 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, 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 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.
Bristol-Myers Squibb (BMS) has secured approval from the European Commission (EC) for melanoma drug Opdivo (nivolumab) two and four-week flat dosing schedule.
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.
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).
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.
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