For the first time in history, the U.S. Food and Drug Administration (FDA) has placed a countrywide import alert for all hand sanitizers from Mexico due to concerns of methanol contamination. Hand sanitizers that are contaminated with methanol are known to result in a...
As an update to the previous release late last year, Japan’s regulatory body, the Pharmaceutical and Medical Device Agency (PMDA), has released its translated English version of the process for conducting remote compliance inspections for drugs and regenerative...
Yesterday (1/25), Australia’s Therapeutic Good Administration (TGA) authorized Pfizer and BioNTech’s COVID-19 vaccine. The provisional approval is the first for COVID-19 vaccines in Australia’s market for individuals 16 years and older and is expected to be...
The U.S. Food and Drug Administration (FDA) announced on Friday (1/22) the first ever approval for Aurinia Pharmaceutical’s Lupkynis oral medication in combination with a background immunosuppressive therapy regimen for lupus nephritis (LN), serious chronic autoimmune...
Curelator, a digital health company based in Cambridge, MA, released its findings for the largest international study that focused on the relationship between stress and migraines in the January issue of Headache, The Journal of Head and Face Pain in collaboration...
Yesterday (1/20), Novavax received provisional determination from Australia’s Therapeutic Goods Administration for its COVID-19 vaccine, marking the first steps in gaining provisional approval. Australia’s provisional approval pathway allows for drug therapies (or...
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