Tag Archives: approval

Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns

Print this page DUBLIN–(BUSINESS WIRE)–Dec. 27, 2018– Horizon Pharma plc (NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for Ravicti (glycerol phenylbutyrate) Oral Liquid to include infants younger than two months of age living with a urea cycle disorder… Read More »

AstraZeneca, Merck's Lynparza plows ahead in ovarian cancer with $1B-plus approval, phase 3 data

The year may be winding down, but AstraZeneca and Merck’s Lynparza sure isn’t. It picked up a blockbuster new approval late Wednesday and followed up the act by posting positive phase 3 data Thursday morning. U.S. regulators green-lighted the fast-growing PARP inhibitor in BRCA-mutated ovarian cancer patients who’ve responded partially or completely to an initial… Read More »

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