Government
When it comes to a novel virus like SARS-CoV2, a certain amount of “rolling with the punches” is required, and governments and global organizations like the World Health Organization are beginning to dismiss certain treatments and devote themselves wholeheartedly to others.
The company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration for two more years.
While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. FDA has remained busy lining up potential approvals of medications for other diseases and illnesses.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 3, 2020.
During a Sunday campaign event in Florida, President Donald Trump appeared to hint to the crowd that following the Nov. 3 election, he would terminate the decades-long tenure of Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
The U.S. – and global – response to the COVID-19 pandemic has been volatile at best. This is fair, considering that SARS-CoV-2 is a novel virus with a lethality we haven’t seen in more than a century.
Excess mortality rates in the U.S. remain high, despite a steady decline since mid-December.
EYSUVIS is the first FDA-approved ocular corticosteroid for the treatment of dry eye disease. Know more about how it got approval and the complete development timeline here.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 27, 2020.
While pre-license inspections of manufacturing sites are typically done following the acceptance of a BLA filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their manufacturing processes.
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