Glenmark is also conducting phase 3 trials of favipiravir as a COVID-19 monotherapy. Source: Devices & Diagnostics Letter

The company plans to launch the product in the first half of 2021. Source: Devices & Diagnostics Letter

The system enables ear tube placements in five minutes. Source: Devices & Diagnostics Letter

Canadian sterile drug manufacturer Viatrexx was hit with an FDA warning letter for serious violations of aseptic practices observed during an agency inspection. Source: Devices & Diagnostics Letter

Keytruda is now approved in China for three different types of cancer. Source: Devices & Diagnostics Letter

The FDA last week cleared EndeavorRx for marketing in the U.S. Source: Devices & Diagnostics Letter

TriNetX is partnering with the FDA’s Sentinel Operations Center at the Harvard Pilgrim Health Care Institute (HPHCI) to monitor priority drugs used for treating hospitalized COVID-19 patients. Source: Devices &…

Enrollment for a large, global trial of chloroquine and hydroxychloroquine for the prevention of COVID-19 is getting under way in the United Kingdom. Source: Devices & Diagnostics Letter

AstraZeneca has nabbed an HHS contract worth up to $1.2 billion to speed development and production of the University of Oxford’s promising COVID-19 vaccine candidate. The deal also would lock…

The FDA added morphine sulfate and epinephrine to the list of compounded drugs under the agency’s temporary policy that allows outsourcing facilities to produce the drugs during the COVID-19 pandemic.…