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Yearly Archives: 2019

Ardelyx’s kidney disease drug succeeded in regulating elevated blood phosphate levels in patients with chronic kidney disease (CKD)

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Dec 04, 2019, Ardelyx lnc said about its experimental drug succeeded in regulating elevated blood phosphate levels in patients with chronic kidney disease (CKD) in a late-stage study....

United States Food and Drug Administration (USFDA) approved Bortezomib for Injection (IV) 3.5 mg/vial for the treatment of cancers in adult patients

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December 04, 2019: Dr Reddy's Laboratories  launched Bortezomib for Injection (IV) 3.5 mg/vial for the treatment of certain types of cancers in adult patients, in...

U.S. Food and Drug Administration (FDA) approved Regenerative Medicine Advanced Therapy (RMAT) designation from the for ADP-A2M4 for the treatment of synovial...

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Dec. 03, 2019: U.S. Food and Drug Administration (FDA) approved Adaptimmune Therapeutic’s  Regenerative Medicine Advanced Therapy (RMAT) designation for ADP-A2M4 for the treatment of synovial...

Immunomedics Resubmits Biologics License Application to FDA for the treatment of metastatic triple-negative breast cancer (mTNBC)

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Dec. 03, 2019: Immunomedics,a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC) announced the resubmission of its Biologics License Application (BLA) to...

The U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational New Drug (IND) application for first-in-human Phase 1b clinical trial of ATRC-101...

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Dec. 03, 2019:The U.S. Food and Drug Administration (FDA) has cleared the Atreca’s Investigational New Drug (IND) application for first-in-human Phase 1b clinical trial...

OSE Immunotherapeutics Announces Positive Results from first-in-human dose-escalation, randomized, double-blind, placebo-controlled Phase 1 trial of Anti-IL-7 Receptor Antagonist OSE-127

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Dec 02, 2019: OSE Immunotherapeutics  announced completion and positive results from the Phase 1 study of OSE-127, a humanized monoclonal antibody with a differentiated...

AstraZeneca divests rights Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in the US and Canada to Cheplapharm Arzneimittel GmbH...

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Dec. 03, 2019: AstraZeneca has agreed to put up for sale the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in...

Co-Diagnostics Gets “Indian FDA” Approval for Infectious Disease Testing (in vitro diagnostic assays)in One of the World’s Biggest Markets

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Dec. 03, 2019: Co-Diagnostics  Inc. announced that Indian regulators have approved five in vitro diagnostic assays to be manufactured and sold by CoSara Diagnostics Pvt Ltd.,...

The History of clinical research

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The evolution of clinical research traverses a long and mesmerizing journey. From the first recorded trial of legumes in biblical times to the first...

FDA approved Pivotal Phase III Trial Design of Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA)

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Dec. 02, 2019: Akari Therapeutics announced the design of a pivotal Phase III pediatric trial in HSCT-TMA following a FDA End-of-Phase II meeting. Akari...

The U.S. Food and Drug Administration (FDA) approved Medical devices (pacemakers and defibrillators)That Help Keep the Heart Beating

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Dec. 02, 2019: The U.S. Food and Drug Administration (FDA) approved Medical devices such as pacemakers and defibrillators that have extended and improved the...

Merck’s Ebola Vaccine (Ervebo) Approved in Europe by the European Commission

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Dec. 03, 2019: Merck with its Researchers, healthcare providers and global health officials finally breathe a sigh of relief after the hardwork of two...
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