Validation is a required component of medical device quality assurance. But device manufactures new to CMMs find it challenging to validate the software an...
Under the adaptive statistical analysis plan, should the CardiAMP Cell Therapy for Heart Failure study be stopped early for anticipated efficacy at this, o...
U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagn...
"Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidl...
Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with canc...
The STARBURST study (ClinicalTrials.gov Identifier: NCT05563272) is a prospective, open label Phase II "basket" study to investigate CAIX expression in pat...
Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate and a median duration of response of 1...
TG ImmunoPharma Co., Ltd. (TGI), a leading biotech company focused on the development of novel immuno-oncology therapies, is pleased to announce that the F...
INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to ...
Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related ...
Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life fo...
FDA provided information to health care providers and facilities on oxygenator devices used in extracorporeal circulation. The FDA issued this letter to ...
Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved commercial production at the company’s...
Nirsevimab would be the first immunization specifically designed to protect all infants through their first RSV season, if approved Across all clinical ...
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