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Yearly Archives: 2019

Zosano Announces FDA Submission of 505(b)(2) New Drug Application for Qtrypta for the acute treatment of migraine

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Dec. 23, 2019: Zosano Pharma Corporation announced the submission of a 505(b)(2) New Drug Application (“NDA”) for Qtrypta™ to the U.S. Food and Drug Administration...

U.S FDA issues complete response letter to ViiV Healthcare for the use of investigational cabotegravir and rilpivirine long-acting regimen for the treatment of HIV

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Dec 21, 2019: ViiV Healthcare received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir...

Let’s learn how to write an ABSTRACT

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What you need to include in a research paper is ABSTRACT: ...

Lets learn how can You summarize any Story/ article or Research Paper

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What is summarizing: Giving a short statement of the important points by removing all extra fat. Why is it important: It allows you to...

Drug Approval process-FDA

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The scope of this blog to give the overview of Drug approval process in US. The regulatory agency of USA is FDA which has...

U.S. FDA approved priority review to sNDA for Braftovi® (encorafenib) in combination with erbitux® (cetuximab) (braftovi doublet) for the treatment of Brafv600e-mutant metastatic colorectal...

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Dec 18, 2019: Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved priority review to the Company’s supplemental New Drug...

Galapagos in collaboration with Gilead submits NDA to U.S. Food and Drug Administration under priority review for filgotinib for rheumatoid arthritis treatment

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Dec 19, 2019: Galapagos NV  announced that its collaboration partner, Gilead Sciences,) has submitted a New Drug Application (NDA) to the U.S. Food and...

Oxidien Pharmaceuticals Announces encouraging Response from FDA on Proposed Development Plan

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Dec 19, 2019: Oxidien Pharmaceuticals, announced that it has received encouraging responses from U.S. Food and Drug Administration (FDA) regarding their proposed Phase 1/2...

Bristol-Myers Squibb Announces Submission of Biologics License Application to the U.S. Food and Drug Administration (FDA) for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel)

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Dec 18, 2019: Bristol-Myers Squibb Company announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for...

FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for the treatment of locally Advanced or Metastatic Urothelial Cancer

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Dec 18, 2019: Seattle Genetics and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV ™...

Novartis provides update on (fevipiprant) LUSTER Phase III studies in patients with uncontrolled GINA 4/5 asthma

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Dec 16, 2019: Novartis announced topline results from its pivotal global Phase III LUSTER-1and LUSTER-2 studies examing the efficacy and safety of the investigational oral,...

Roche concludes getting hold of Spark Therapeutics, Inc. to reinforce presence in gene therapy

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Dec 17, 2019: Roche and Spark Therapeutics, Inc. announced the completion of the acquisition following the receipt of regulatory approval from all the government...
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