The U.S. Food and Drug Administration (FDA) has amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the...
The FDA has recently approved a cell therapy called Omisirge (omidubicel-onlv) for patients with blood cancers who are undergoing stem cell transplantation. This allogeneic cord blood-based...
Candida auris is a fungus that has caught the attention of many healthcare professionals and institutions globally. This emerging fungus poses a significant threat to public...
The FDA has approved the Azure Fastep COVID-19 Antigen Pen Home Test, a quick and convenient option for serial testing for symptomatic and asymptomatic individuals.
The FDA warns about hand sanitizer safety and advises following the Drug Facts label and safety tips to avoid harm from toxic substances, accidental fires, eye...
Agency Continues to Take Steps to Reduce New Cases of Opioid Use Disorder
The U.S. Food and Drug Administration released a national strategy outlining actions the agency will take immediately to help ensure one of the nation’s most vulnerable...
The FDA issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications.
“Diet-related chronic diseases, are the leading causes of death and disability in the U.S.
Manufacturer Must Monitor Consumer Impact; FDA May Withdraw Authorization as Needed to Protect Public Health Today, the U.S. Food and Drug Administration authorized U.S. Smokeless Tobacco Company’s...