ADMA Biologics announced today (2/1) that the U.S. Food and Drug Administration (FDA) has granted approval for the ADMA BioCenters Plasma Collection Facility in Knoxville, Tennessee. Adam Grossman, President and Chief Executive Officer of ADMA, stated, “The approval...
The European Medicine’s Agency (EMA) announced today (1/29) it’s approval of the AstraZeneca and University of Oxford’s COVID-19 vaccine. The approval marks the third vaccine passed by the EMA. The vaccine is administered as two doses, with the second coming between 4...
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...
On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s...
Seneca Biopharma announced today (1/20) its preliminary top-line results for their Phase 2 ischemic stroke study. The trial, which took place in Beijing, China, focused on evaluating the relative safety of NSI-566, a neural stem cell therapy, in patients afflicted...
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