By Megan Redshaw, J.D. The 21st Century Cures Act (Cures Act), signed into law in December 2016, was created to help accelerate medical product development and…
Posts tagged as “FDA”
The documents, previously submitted by Moderna to the U.S. Food and Drug Administration as part of the licensing process for Moderna’s Spikevax COVID-19 vaccine, included…
By Michael Nevradakis, Ph.D. The U.S. Food and Drug Administration (FDA) had the opportunity to improve COVID-19 vaccine labeling — but according to a team…
Advisors to the U.S. Food and Drug Administration on Thursday recommended approval of AstraZeneca’s new monoclonal antibody, which the drugmaker said is designed to protect…
by Jacob M. Thompson “When people believe, and act on, misinformation the public’s health suffers,” the FDA says. On May 22nd the United States…
By Michael Nevradakis, Ph.D. Advisers to the U.S. Food and Drug Administration (FDA) on Thursday recommended, by a vote of 10 to 4, that…
By Anthony T The FDA has officially loosened its restrictions for gay and bisexual blood donors. On Thursday the FDA will start asking gay and bisexual…
By Amy Denney Clinical trials indicate success but there are risks and many unknowns in the novel therapy Patients needing a fecal microbiota transplant…
by Jacob M. Thompson “The original intent in making these animals was to try to improve the way that we feed people. And we can’t…
By Reuters A panel of U.S. Food and Drug Administration (FDA) advisers on Friday voted for the restricted use of British drugmaker AstraZeneca…
BY BEN BARTEE The court-mandated release of the documents related to what Pfizer and the FDA knew about the COVID-19 injections and when has unearthed evidence that…
By JESSICA ROSE “The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.” Head to the…
By Anthony Scott In a press release on Tuesday, the FDA has declared the monovalent Pfizer and Modena mRNA Covid-19 vaccines are no “longer authorized for use…
By Clyde Hughes & Matt Bernardini April 14 (UPI) — The Supreme Court on Friday temporarily blocked a lower court’s ruling preventing access to mifepristone by mail, handing a victory to…
Three former executives of Magellan Diagnostics deliberately concealed a problem with the company’s lead-testing devices that produced inaccurately low results for tens of thousands of…
Prescriptions for stimulant drugs such as Adderall spiked, especially among young women, during the pandemic when more people used telehealth services, a new Centers for…
by Jacob M. Thompson “A more promising approach would be mRNA vaccines, which proved incredibly versatile for rapid scaling during Covid-19, as well as outshining…
by daniel_g Pfizer has another dangerous injection down the pipeline that the U.S. Food and Drug Administration (FDA) appears poised to approve. The pharmaceutical…