With an effective process validation regimen – with proper documentation and protocol testing to address product identity, strength, quality, purity,...
New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especi...
Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon...
In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy...
The DENEX system is an innovative medical device that treats hypertension using minimally invasive renal denervation technology. Electrodes are inserted in...
RIM Smart Labeling is part of IQVIA’s suite of purpose-built regulatory, safety and quality technology solutions and services. Label management is an...
CAMZYOS is the first and only cardiac myosin inhibitor approved in the European Union Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALO...
U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedeli...
Validation is a required component of medical device quality assurance. But device manufactures new to CMMs find it challenging to validate the software an...
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that the U.S. Federal Bureau of Investigation (FBI) has approved its ForenSeq® Mains...
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...
Initiating legal proceedings against medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and desist fr...
"Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidl...
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