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Yearly Archives: 2020

The U.S. FDA is alertes safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)

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Jan 14, 2020: The U.S. FDA is alerting the public that results from a clinical trial assessing safety shows possible increased risk of cancer...

Impact Factor

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Since a long time, Impact factor (IF) has been used as a key indicator of importance of a journal in a particular field. The...

Bristol-Myers Squibb Company announced U.S. FDA accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line...

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Jan 15, 2020: Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) with Yervoy (ipilimumab) for...

Imago Receives Fast Track Designation from U.S. FDA for Bomedemstat for the Treatment of Essential Thrombocythemia

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Jan 12, 2020: Imago BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of...

MorphoSys and Incyte Sign Global Collaboration and License Agreement for Tafasitamab development for the treatment of the B cell malignancies

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Jan 13, 2020: MorphoSys AG and Incyte Corporation  announced that the companies have entered into a collaboration and license agreement to further develop and...

CytoDyn Files for Breakthrough Therapy Designation with the FDA for the Use of Leronlimab as an adjuvant therapy for the Treatment of Metastatic Triple-Negative...

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Jan. 13, 2020:  CytoDyn Inc. announced that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA)...

Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for the treatment of Tumor-Induced Osteomalacia (TIO)

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Jan. 13, 2020: Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd. announced that they submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA)...

BioCryst to Provide Berotralstat and BCX9930 Program Updates at 38th Annual J.P. Morgan Healthcare Conference

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Jan. 12, 2020:  BioCryst Pharmaceuticals, Inc. announced that the company will provide updates on berotralstat, an oral kallikrein inhibitor for hereditary angioedema (HAE), and BCX9930,...

FDA grants breakthrough device designation to Reflow Medical’s temporary spur stent system for the treatment of below-the-knee (BTK) peripheral artery disease

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Jan 10, 2020: U.S. Food and Drug Administration (FDA) announced Reflow Medical’s Temporary Spur Stent System, a novel retrievable stent technology proposed for the...

Novartis ligelizumab (QGE031) more effective than Xolair®(omalizumab) at inhibiting immunoglobulin E pathway responsible for chronic spontaneous urticaria

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Jan 09, 2020: Novartis, a leader in immuno-dermatology, announced mechanistic study results showing ligelizumab is more efficient at inhibiting the major pathogenic IgE/FcεRI pathway...

Bayer and Evotec form a new strategic alliance focusing on the treatment of polycystic ovary syndrome

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Jan 09, 2020: Evotec SE and Bayer AG announced the expansion of their partnership in women’s health indications with a new five-year, multi-target collaboration...

Approval pathways of Fixed dose combination (FDC) in India

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Fixed dose combination (FDC) approval process is a little different from the drug approval process in India. ...
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