Designation confers advantages including marketing exclusivity and tax credits Padeliporfin VTP Phase 1 trial in Pancreatic cancer to start b...
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...
U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedeli...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...
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 ...
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