logo
Plus   Neg
Share
Email

AZN:FDA Accepts Regulatory Submission For Selumetinib In Neurofibromatosis Type1

AstraZeneca (AZN.L,AZN) and Merck & Co., Inc. said that the US Food and Drug Administration has accepted a New Drug Application and granted Priority Review for selumetinib as a potential new medicine for paediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs).

AstraZeneca that it is the first acceptance of a regulatory submission for an oral monotherapy for the treatment of NF1, a rare and incurable genetic condition. A Prescription Drug User Fee Act date is set for the second quarter of 2020.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Apple Inc. (AAPL) Wednesday reported a first-quarter profit that trumped Wall Street estimates, as the iPhone maker reported its "highest quarterly revenue ever" driven by strong demand for its iPhone 11 and 11 Pro models during the holiday season. The tech giant also issued a strong revenue outlook... New York Attorney General Letitia James has fled a lawsuit against Vyera Pharmaceuticals and two of its former CEOs, including imprisoned 'Pharma Bro' Martin Shkreli, for illegally monopolizing a life-saving drug Daraprim. The lawsuit seeks a lifetime ban on Shkreli and his business partner Kevin Mulleady working in the pharmaceutical industry. Graco Inc. (GGG) shares were climbing more than 7 percent in morning trade. Monday after market close, the company had reported a surge in the fourth-quarter earnings to $84.8 million from $73.7 million in the prior year. Earnings per share surpassed analysts' estimates. Sales were up 1 percent to $412.3...
Follow RTT
>