Exclusive: Thermo Fisher's plant making infant RSV drug breached FDA …
WEB2 days ago · Thermo Fisher's Greenville, N.C. plant has been found in breach of US FDA regulations, including twice this year. FDA's most recent inspection of Thermo Fisher plant found...
Exclusive-Thermo Fisher's Plant Making Infant RSV Drug Breached FDA …
WEB2 days ago · (Reuters) -One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years has repeatedly breached rules meant to ensure drugs are...
Thermo Fisher plant making Astra/ Sanofi RSV drug reportedly
WEBA recent FDA inspection has reportedly found issues at a Thermo Fisher (NYSE: TMO) plant in Greenville, N.C., during a production run for Beyfortus, a treatment developed by AstraZeneca...
Thermo Fisher plant making infant RSV drug breached FDA rules
WEB2 days ago · Investing.com -- One of the biggest contract drug manufacturing plants in the US owned by Thermo Fisher Scientific (NYSE: TMO) has repeatedly broken rules designed to ensure that medications...
Thermo Fisher Scientific Announces FDA Clearance of …
WEBMay 19, 2023 · Investor Relations. News, Events & Presentations. View All News. Thermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia. May 19, 2023. First and only blood-based biomarkers for the risk assessment and clinical management of preeclampsia with severe features.
Thermo Fisher's (TMO) CDx Gets FDA's Nod for Synovial Sarcoma
WEBAug 13, 2024 · Thermo Fisher Scientific TMO recently secured FDA’s 510 (k) clearance for its SeCore CDx HLA A Sequencing System for use as a companion diagnostic (CDx) alongside Adaptimmune ’s ADAP newly...
Thermo Fisher Scientific Announces FDA Clearance of …
WEBMay 19, 2023 · WALTHAM, Mass.-- ( BUSINESS WIRE )--Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has...
Thermo Fisher Scientific Announces Extended 510k Clearance of …
WEBBIRMINGHAM, England, July 29, 2024--Thermo Fisher Scientific Inc., the world leader in serving science, today announced it has been 510k cleared, following US Food and Drug Administration...
Thermo Fisher gets FDA clearance for first blood test of severe ...
WEBMay 22, 2023 · Thermo Fisher Scientific received clearance from the Food and Drug Administration for the first blood test to predict the risk of severe preeclampsia, a life-threatening hypertensive disorder that occurs only …
Thermo Fisher's test to detect pregnancy-related complication gets FDA …
WEBMay 19, 2023 · The U.S. Food and Drug Administration (FDA) has cleared Thermo Fisher Scientific Inc's test, the first of its kind in the country, to detect women with risk of severe preeclampsia, the company...