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Yearly Archives: 2019

US Food and Drug Administration (FDA) approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

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Nov 21,2019: AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small...

U.S. FDA approved IN.PACT AV paclitaxel-coated balloon for the treatment of Arteriovenous Fistula Lesions

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Nov. 21, 2019: Medtronic  announced U.S. Food and Drug Administration (FDA) approval of the IN.PACT™ AV drug (paclitaxel)-coated balloon for the treatment of failing...

Zydus receives final approvals from the USFDA for Isosorbide Dinitrate Tablets for the treatment of Angina and Desonide Cream for skin diseases

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Nov. 21, 2019: Zydus Cadila has received the final approval from the USFDA for marketing Isosorbide Dinitrate Tablets USP ( 5 mg, 10 mg,...

Astellas and Welldoc together develop and commercialize BlueStar® a digital health solution cleared by the U.S. Food and Drug Administration (FDA) for the...

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Nov 20, 2019  - Astellas Pharma Inc. and Welldoc, Inc. announced that the companies have entered into a collaboration and license agreement directed toward the development and commercialization...

Officials:Blackberries sold in Fresh Thyme grocery stores cause hepatitis A

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Nov 21,2019: Consumers of 11 states are warned by Nebraska and federal health officials as hepatitis A outbreak that includes Nebraska, Indiana and Wisconsin...

NGFA–KSU Food Safety Modernization Act Feed Industry Training course to set regulations for safe animal feed

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Nov. 20, 2019: FDA has issued final regulations under the Food Safety Modernization Act that require feed facilities to comply with new current...

USFDA Approved GIVLAARI(givosiran) for the Treatment of Adults with Acute Hepatic Porphyria

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Nov. 20, 2019: Alnylam Pharmaceuticals, the leading RNAi therapeutics company, announced  the USFDA approved GIVLAARI™ (givosiran) injection (subcutaneous) for the treatment of adults with acute hepatic...

Merck’s anti-PD-1 therapy KEYTRUDA(pembrolizumab) for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

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Nov 20,2019: For the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1...

Due to Potential Battery Failure Getinge’s Maquet / Datascope Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP)

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Nov 19, 2019: USFDA provides an update on failure related to Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices (Cardiosave Hybrid and Cardiosave Rescue). From...

First-in-human clinical trial to evaluate CAR-Treg Cell Therapy TX200 for Kidney Transplantation approved for Phase 1/2 Clinical Trial

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Nov 19, 2019: Sangamo Therapeutics announced that the UK Medicines Healthcare Products Regulatory Agency (MHRA) has granted authorization of the first-in-human clinical trial to evaluate a...

KarXT enrolled in Phase II clinical trial for the treatment of acute psychosis in schizophrenia patients

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Nov 19, 2019: Karuna Therapeutics  announced  that KarXT assured for the treatment of acute psychosis in schizophrenia patient sign up in a Phase II...

TWILIGHT trial showed that Brilinta (ticagrelor) monotherapy reduced the risk of clinically relevant bleeding compared to dual antiplatelet therapy (DAPT) in patients with non-ST...

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Nov 17, 2019: From subgroup analysis of the TWILIGHT trial in patients with non-ST elevation acute coronary syndromes(NSTE-ACS), Brilinta (ticagrelor) monotherapy reduced the risk of...
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