Omeros, MannKind-United Therapeutics, and Revance Therapeutics were issued Complete Response Letters from the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
An injection to treat forehead wrinkles is set to rival Allergan plc’s Botox after U.S. regulators approved Evolus Inc.’s cheaper treatment, sending the Newport Beach, Calif.-based company’s shares up about 5 percent.
A potential rival for Allergan Plc’s blockbuster Botox passed a late-stage study, putting drug developer Revance Therapeutics Inc. on course to file for U.S. marketing approval in 2019.
Dublin-based Allergan is acquiring Newport Beach, California-based Bonti with an upfront payment of $195 million.