Regulatory
A recent study questions if the FDA and other regulatory agencies worldwide rush certain approvals, particularly at the end of the year in a kind of “desk-clearing” activity.
Polyganics announced that it has obtained CE marking for LIQOSEAL®, its easy-to-use and innovative dural sealant patch, and will launch the device in Europe with immediate effect.
This is a list of new molecular entities and new therapeutic biological products approved by the agency’s Center for Biologics Evaluation and Research in 2019.
Company will present at Biotech Showcase™ 2020 on Monday, 01/13/20 at 11:15am PST in San Francisco, CA
The clinical trials the approval is based on suggested the drug was effective for treating primary insomnia but may also be effective for insomnia associated with other diseases, such as depression.
Specifically, it was approved for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.
The U.S. Government is increasing the measures it is taking to counter what it sees as a growing threat to scientific intellectual property from China.
Moving into the holidays and the fast-approaching end of the year, the U.S. Food and Drug Administration (FDA) got busy wrapping up a number of to-do items. Here’s a look.
At the Drug Development Unit at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust in London, the first patient in Phoenix’s first in human “ACTivate Trial” has received ACT® in combination with chemotherapy for treatment of hepatic metastases associated with colorectal and pancreatic cancer.
Reston Hospital has received verification as a Level II Trauma Center by the American College of Surgeons for a period of three years through the year 2022.
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