Regulation

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).

ViiV Healthcare seeks FDA approval for cabotegravir plus rilpivirine to treat HIV

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.

LYNPARZA receives positive CHMP opinion for BRCA-mutated advanced ovarian cancer

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 seeks EMA approval for luspatercept for anemia associated with MDS and beta-thalassemia

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 receives positive CHMP opinion for TALZENNA for patients with inherited BRCA-mutated locally advanced or metastatic breast cancer

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).

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).