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Monthly Archives: May, 2020

Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients

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May 09, 2020: "The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new...

Clinical Research Associate: Role, Responsibilities, Skills, and Salary

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Introduction: Clinical Research Associate may be employed directly by the sponsor companies of clinical trials or by Clinical Research Organizations (CROs) CROs conduct clinical trials...

Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens

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May 08, 2020: "The U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for...

Coronavirus (COVID-19) Update: Daily Roundup May 8, 2020

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May 08, 2020: The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19...

FDA Approves First Therapy for Patients with Lung and Thyroid Cancers

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May 08, 2020: "The U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung...

U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study

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May 8, 2020: "Pluristem Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s IND application for a Phase...

PharmaCyte Biotech Receives Medical Devices Registration and Submits Pre-EUA Application to the FDA for COVID-19 Diagnostic

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May 6, 2020: "PharmaCyte Biotech announced that it has received Medical Devices Establishment Registration with the FDA’s Center for Devices and Radiological Health (CDRH)....

RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study

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May 08, 2020: "RedHill Biopharma Ltd. announced that the U.S.FDA has approved its IND application for a Phase 2a clinical study evaluating its investigational drug,...

Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 ADVANCE Study

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May 06, 2020: "Amgen announced positive top-line results from the ADVANCE trial, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of...

FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure

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May 8, 2020: "Amgen and Cytokinetics, Incorporated announced that the U.S.FDA has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator, also known as...

CDC scientists honored as 2020 Service to America Medal Finalists

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May 08, 2020: "Centers for Disease Control and Prevention Control (CDC) scientists Dr. Vikram Krishnasamy, and Dr. Peter Briss and the 2019 Lung...

Gilead Announces Approval of Veklury® (remdesivir) in Japan

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May 7, 2020: "Gilead Sciences, Inc. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury® (remdesivir) as a treatment...
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