Food and Drug Administration (FDA)

NEWS
FDA
Shares of Heron Therapeutics climbs after it announced the U.S. FDA approved its non-opioid drug for extended pain relief following some surgeries.
Comments on social media provide a glimpse at the deep divide in trust of public health agencies, and now a new survey demonstrates the breadth of that distrust.
The Rare Disease Company Coalition’s 10 founding members have brought 22 treatments to market and currently have more than 160 rare disease programs in the works.
Pivotal data from Amgen’s and AstraZeneca’s NAVIGATOR Phase III trial show tezepelumab, a potential first-in-class human monoclonal antibody, reduced asthma aggravations and exacerbations requiring hospitalizations better than placebo in patients with severe asthma.
FDA
There was a lot of news and research studies today related to the COVID-19 vaccines. Here’s a look.
FDA
Merck announced positive results from the late-stage KEYNOTE-522 study that should support its previous attempt that was stymied by a regulatory advisory committee in February and rejected by the U.S. FDA in March.
New mutations of the SARS-CoV-2 virus are continuing to be discovered. As we’ve seen from the most common variants of the virus, infectiousness appears to be the trait most familiar to all of them.
Clearance of the IND allows Samus to proceed with a Phase Ib trial to assess the safety, tolerability and pharmacokinetics of PU-AD in a small group of patients with recurrent malignant glioma.
FDA
The U.S. FDA expanded the Emergency Use Authorization for the Pfizer and BioNTech vaccine to include adolescents ages 12 to 15 after clinical data showed 100% efficacy response.
JOBS
IN THE PRESS