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Yearly Archives: 2020

FDA grant approval for GSK’s Voltaren Arthritis Pain for over-the-counter use in the United States

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Feb 17, 2020: GlaxoSmithKline announced that the U.S.FDA has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an...

Health ministry issues notification to regulate all the medical devices under D&C Act from April 1, 2020

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Feb 11, 2020: Union health ministry has notified that all the medical devices will nowadays regulated under the Drugs and Cosmetics (D&C) Act, 1940...

New Phase IIIb Interim Data from the STARDUST Study Shows about Two-Thirds of Patients with Moderately to Severely Active Crohn’s Disease Achieved Clinical Remission...

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Feb. 14, 2020: The Janssen Pharmaceutical Companies of Johnson & Johnson announced temporary data from the Phase IIIb STARDUST study. At week 16, 79 per cent...

Deciphera Pharmaceuticals Announces U.S. FDA Acceptance of NDA and Priority Review for Ripretinib in the Patients with Advanced Gastrointestinal Stromal Tumors

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Feb. 12, 2020: Deciphera Pharmaceuticals announced that the U.S. FDA has accepted for Priority Review its NDA seeking approval for ripretinib, the Company’s investigational broad-spectrum KIT...

U.S.FDA Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application for the Lisocabtagene Maraleucel (liso-cel) for the Adult Patients with Relapsed or Refractory Large...

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Feb 13, 2020: U.S.FDA accepted for the Priority Review its Biologics License Application (BLA) for BMS’s lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 chimeric...

Merck’s Checkpoint Inhibitor Keytruda (pembrolizumab) Hits Another Mark in Breast Cancer

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Feb 12, 2020: Merck’s checkpoint inhibitor Keytruda (pembrolizumab) proved itself efficient in yet another cancer indication. The company announced positive results from the pivotal Phase III KEYNOTE-355...

Eli Lilly Announces Topline Results for the Solanezumab from the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study

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Feb 10, 2020: Eli Lilly and Company announced that the analysis performed by the Washington University School of Medicine in the Dominantly Inherited Alzheimer Network Trials...

Novartis announces MET inhibitor capmatinib, the first potential treatment for the METex14 mutated advanced non-small cell lung cancer, granted priority FDA review

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Feb 11, 2020:  Novartis announced that the U.S.FDA accepted and granted Priority Review to capmatinib’s (INC280) NDA. Capmatinib is a MET inhibitor being evaluated...

Bayer and Nuvisan generate new research unit in Berlin

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Feb 11, 2020: Bayer AG announced that it entered into a definitive agreement to transfer a large part of its Berlin-based small molecule research...

U.S. FDA granted fast track designation for Nanobiotix for the investigation of first-in-class nbtxr3 in head and neck cancer

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Feb 10, 2020: NANOBIOTIX , a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer announced that the U.S. FDA  has granted...

Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for the review of NDA for the combination oral hypomethylating agent cedazuridine and decitabine...

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Feb 11, 2020: Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan  announced that the U.S. FDA has accepted...

U.S. FDA Acceptance of New Drug Application for FibroGen’s Roxadustat for the Treatment of Anemia of Chronic Kidney Disease

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Feb. 11, 2020: FibroGen announced that the U.S.FDA has completed its filing review of its New Drug Application (NDA) for roxadustat for the treatment...
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