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 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).
ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for the investigational, monthly, injectable, two-drug regimen of cabotegravir and rilpivirine to treat HIV.
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending LYNPARZA as a first-line maintenance treatment in BRCA-mutated advanced ovarian cancer.
Celgene and Acceleron Pharma have a filed an application with the European Medicines Agency (EMA) seeking approval for luspatercept for the treatment of anemia associated with myelodysplastic syndromes (MDS) and beta-thalassemia.
Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorization in the European Union (EU).
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 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).
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 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).
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