Regulatory
the robustness and independence of FDA review – even under an EUA – is an important factor in encouraging a skeptical public to accept COVID-19 vaccinations.
The U.S. Food and Drug Administration has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood.
The United Kingdom’s Medicines & Healthcare Products Regulatory Agency granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2.
The FDA uses special designations to get new, breakthrough treatments to patients in the greatest need.
As the year winds down, the top companies in the COVID-19 vaccine race are nearing the finish line in the United States and other countries around the world.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 1, 2020.
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency.
Moderna announced that it plans to submit its request to the U.S. Food and Drug Administration for an Emergency Use Authorization for its COVID-19 vaccine, mRNA-1273.
The interim final rule aligns payment for Medicare Part B therapeutics with international prices and removes incentives for physicians to prescribe more expensive drugs and biologics.
The end of November and beginning of December is marked by several PDUFA dates at the U.S. Food and Drug Administration (FDA). Here’s a look.
PRESS RELEASES