Regulation

Sandoz secures FDA approval for pegfilgrastim biosimilar Ziextenzo

Novartis’ Sandoz unit has secured approval for Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgen’s Neulasta (pegfilgrastim) from the US Food and Drug Administration (FDA).

Sanofi’s Fluzone quadrivalent formulation gets FDA nod in older people

Sanofi’s Fluzone High-Dose Quadrivalent (Influenza Vaccine) has secured approval from the US Food and Drug Administration (FDA) for its use in adults, aged 65 and over.

Roche’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA

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.

FDA grants fast track status to Terns’s FXR agonist to treat NASH

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).

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.