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Yearly Archives: 2019

EVENITY® (romosozumab) approved by European Commission (EC) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture

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Dec. 11, 2019: Amgen and UCB announced that the European Commission (EC) has granted marketing authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women...

U.S. FDA OKs for Pfizer’s XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis

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Dec 12, 2019: U.S. Food and Drug Administration (FDA) has approved Pfizer’s  XELJANZ ® XR (tofacitinib) extended-release 11 mg and 22 mg tablets for...

The U.S. Food and Drug Administration granted accelerated approval for the first targeted treatment, Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy

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December 12, 2019: The U.S. Food and Drug Administration granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) for...

Innovative diabetes management solution (Accu-Chek SugarView app) announced by Roche

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Dec 10, 2019: Roche announced that it has obtained the CE Mark for its Accu-Chek SugarView app, innovative diabetes management solution in Europe and...

Daiichi Sankyo Initiates Pivotal Phase 2 Trial in Japan with Valemetostat to treat patients with adult T-cell leukemia-lymphoma

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Dec 10, 2019: Daiichi Sankyo Company, Limited announced  that the first patient has been dosed in a pivotal phase 2 study in Japan evaluating...

Healx collaborates with Boehringer Ingelheim to discover new treatment approaches for rare neurological diseases

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Dec 09, 2019: Healx the AI-powered biotechnology company, announces that it has entered into an agreement with Boehringer Ingelheim to identify indications related to...

GenesisCare launched UK’s first MRIdian radiotherapy machine: a new radiotherapy treatment to reduce treatment time

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Dec. 10, 2019: Cancer patients can begin from today potential access to the UK’s first MRIdian machine, a new radiotherapy treatment to reduce treatment...

FDA OKs to Navigen for its IND Application to Initiate First-in-Human Studies for CPT31, a Novel, D-peptide HIV Entry Inhibitor

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Dec. 10, 2019: Navigen, Inc. announced that the U.S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug application ("IND") for the...

Sesen Bio Initiates Rolling Submission of BLA for Vicinium to FDA for the treatment of BCG-unresponsive non-muscle invasive bladder cancer

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Dec  09, 2019: Sesen Bio announced that on December 6, 2019, the Company initiated the submission of its Biologics License Application (BLA) for Vicinium for...

First and only ingestible event marker (the ID-Cap® System)approved by U.S. FDA

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Dec 09, 2019: EtectRx® Inc. announced U.S. Food and Drug Administration (FDA) clearance of its breakthrough patented ingestible event marker, the ID-Cap® System (first and...

Moberg Pharma meets primary endpoint for MOB-015 (topical terbinafine) in a phase 3 study for the treatment of Onychomycosis

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Dec 9, 2019: Moberg Pharma announces that MOB-015 (topical terbinafine) met the primary endpoint and also key secondary endpoints in the North American Phase...

U.S. FDA approved Fast Track designation for Equillium’s itolizumab (EQUALISE Phase 1b study )for the treatment of lupus nephritis

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Dec. 09, 2019 : The U.S. Food and Drug Administration (FDA) approved Fast Track designation for Equillium’s itolizumab for the treatment of lupus nephritis. Equillium...
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