Regulatory

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.
Arimoclomol will be reviewed under Priority Review with a PDUFA date of March 17, 2021. Here’s more about it.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 14, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.
FDA
GlaxoSmithKline’s Trelegy Ellipta won regulatory approval for the treatment of asthma in patients aged 18 years and older. Here’s what you need to learn.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 9, 2020.
Using gene therapy to edit embryos, sperm or eggs in order to improve health conditions in a child should not be conducted due to the unreliability of the science, as well as due to significant ethical and moral concerns.Those are the words found in new guidance established this week.
Shares of Amarin Corporation are down more than 3% in premarket trading after the company reported Thursday that a panel of three judges from the U.S. Court of Appeals upheld a lower court’s ruling that paved the way for generic competition for the company’s heart disease drug, Vascepa.
When Moncef Slaoui was tapped to helm Operation Warp Speed, he sought confirmation that politics would not play a role in driving certain treatments through an approval process without the proper supporting scientific data to back it up.
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