Approvals

Viela Bio receives US FDA breakthrough therapy designation for Inebilizumab to treat Neuromyelitis Optica Spectrum Disorder

Viela Bio announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the Company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD).

AqVida, Phyton receive approval from EDQM for AqVida’s paclitaxel injectable FDF

Phyton Biotech, a German/North American Plant Cell Fermentation (PCF) technology company, and AqVida, a German oncology Finished Dosage Formulation (FDF) manufacturer, are pleased to announce today that they have received European approval from the EDQM (European Directorate of Quality Medicines) for AqVida’s paclitaxel injectable FDF.

FDA approves DUAKLIR PRESSAIR to treat chronic obstructive pulmonary disease

Circassia Pharmaceuticals announced that the US Food and Drug Administration has approved DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

FDA grants orphan drug designation to NeoImmuneTech’s Hyleukin-7 for idiopathic CD4+ lymphocytopenia treatment

NeoImmuneTech (NIT), a T cell-focused therapeutics company, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Hyleukin-7T, a T cell amplifier, in development for the treatment of Idiopathic CD4+ Lymphocytopenia (ICL).

Janssen’s Balversa gets FDA approval for metastatic bladder cancer

Johnson & Johnson’s Janssen Pharmaceutical has secured accelerated approval for Balversa (erdafitinib) from the US Food and Drug Administration (FDA) for the treatment of metastatic bladder cancer.

Wockhardt receives US FDA approval for cancer drug

Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 50mg injection of Decitabine, which is used to treat certain forms of cancer.

Amgen gets FDA approval for Evenity to treat osteoporosis in postmenopausal women

Amgen has secured approval from the US Food and Drug Administration (FDA) for its Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk for fracture.

ViiV Healthcare gets FDA approval for HIV drug Dovato

ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Dovato (dolutegravir/lamivudine) for treatment-naïve HIV-1 adults.

Pfizer gets EC approval for Vizimpro lung cancer monotherapy

Pfizer has secured approval from the European Commission (EC) for its Vizimpro (dacomitinib) as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.