Approvals

FDA approves KALYDECO for treatment of eligible infants with cystic fibrosis

Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO (ivacaftor) for use in children with cystic fibrosis (CF) ages six months to less than 12 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data.

Finch Therapeutics receives fast track designation for investigation of Full-Spectrum Microbiota as treatment for children with autism spectrum disorder

Finch Therapeutics Group announced that the US Food and Drug Administration (FDA) has granted fast track designation to its Full-Spectrum Microbiota (FSM) therapy for the treatment of children with Autism Spectrum Disorder (ASD).

GSK gets FDA nod for Benlysta to treat pediatric patients with lupus

GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Benlysta (belimumab) intravenous (IV) infusion to treat children with systemic lupus erythematosus (SLE).

Knopp Biosciences gets FDA orphan drug designation for dexpramipexole tp treat hypereosinophilic syndrome

Knopp Biosciences announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to dexpramipexole, its oral drug candidate for the treatment of hypereosinophilic syndrome (HES).

FDA approves Merck’s Keytruda plus Inlyta to treat advanced renal cell carcinoma

Merck has secured approval from the US Food and Drug Administration (FDA) for Keytruda in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma (RCC).

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).