Regulatory
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.
“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Alex Azar, Secretary of HHS.
The FTC alleges that Illumina is trying to unlawfully maintain a monopoly in the U.S. market for next-generation DNA sequencing systems by removing PacBio as a competitive threat.
Follows recent study results showing CelGro® facilitates high quality nerve repair and restores function to previously paralysed muscles
Baebies is pleased to announce that FINDERTM, a near-patient testing platform, now has CE Mark as an In Vitro Diagnostic device and is commercially available in Europe and other countries that recognize CE Mark.
If approved by the European Commission, the daratumumab-VTd regimen would represent the first therapeutic option indicated for newly diagnosed patients who are eligible for a stem cell transplant in six years
Positive Opinion is based on data from the Phase 3 TITAN study which were published in The New England Journal of Medicine
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