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Yearly Archives: 2019

Important data points in Protocol for CRFs Creation (CDM Prospective):

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Reading of whole protocol is quite important and indispensable act but by keeping following points in mind, one can read protocol with more clarity...

Parts of a clinical trial protocol and Clinical Data Management (CDM) prospective to review

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This blog talks about Protocol parts and key information needed for any Data Manager to design CRF. Protocols are quite specific to studies but share some...

Only treatment approved in the US for relapsed or refractory hairy cell leukemia Approved by FDA at ASH 2019

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Dec. 08, 2019: Innate Pharma shared new, long-term data from the pivotal Phase III trial of Lumoxiti (moxetumomab pasudotox-tdfk) at the 61st American Society...

Amgen’s AVSOLA™ received FDA approval for AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)for the treatment of Rheumatoid Arthritis, Crohn’s Disease, Ulcerative Colitis,...

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Dec. 6, 2019: U.S. FDA has approved Amgen’s  AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid...

ViiV Healthcare submits New Drug Application to the US FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults

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Dec 05, 2019: ViiV Healthcare have completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in search...

FDA authorizes marketing of diagnostic test cobas vivoDx that uses novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacteria

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Dec 05, 2019: Roche Molecular Systems Inc. received U.S. Food and Drug Administration approval for marketing of a new diagnostic test (Cobas vivoDx) based...

First investigational drug therapy for liver disease non alcoholic steatohepatitis (NASH) awaiting FDA approval

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Dec. 05, 2019: A large Phase III clinical trial designed in collaboration with Virginia Commonwealth University is the first to demonstrate the safety and...

Data fron XOSPATA® in FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia at the 2019 American Society of Hematology Annual Meeting

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Dec. 3, 2019: Astellas Pharma Inc. announced the presentation of new data in acute myeloid leukaemia (AML) at the 61st American Society of Hematology (ASH)...

First generics of Gilenya approved by FDA for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients

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Dec 05, 2019: The U.S. Food and Drug Administration approved three applications for the first generics of Gilenya (fingolimod) capsules for the treatment of...

U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Alecto’s investigational therapeutic AL001, for the treatment of patients with...

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Dec. 05, 2019: U.S. Food and Drug Administration (FDA) has granted Fast Track designation for  Alecto’s investigational therapeutic, AL001, for the treatment of patients...

U.S. FDA approved BMS Breakthrough Therapy Designation for ORENCIA® (abatacept) just to help in Preventing Acute Graft-Versus-Host Disease, a Potentially Life-Threatening Complication...

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DEC 04, 2019: Bristol-Myers Squibb Company  announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the...

U.S. Food and Drug Administration (FDA) approved Investigational New Drug (IND) application for Dominant Negative PD-1 “Armored” Next Generation CAR-T Cell Therapy

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Dec. 04, 2019: Innovative Cellular Therapeutics (ICT) announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND)...
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