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WuXi Biologics (Suzhou) Successfully Passed First EMA GMP Inspection
prnasia
April 14, 2020
WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platform, announced that WuXi Biologics (Suzhou) Co., Ltd. has successfully passed its first GMP inspection by the European Medicines Agency (EMA), with
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FDA approves first therapy for rare joint tumor
drugs
August 05, 2019
The U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT)...
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FDA approves first treatment for severe hypoglycemia that can be administered without an injection
worldpharmanews
July 30, 2019
The U.S. Food and Drug Administration today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without ...
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Precigen Announces First Patient Dosed in PRGN-3006 UltraCAR-T™ Study
americanpharmaceuticalreview
June 28, 2019
Precigen announced that the first patient has been dosed with PRGN-3006, a first-in-class investigational therapy using Precigen's non-viral UltraCAR-T™ therapeutic platform.
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Dompé Announces First Patient Enrollment in Novel MOA Trial in Moderate to Severe Dry Eye Disease
americanpharmaceuticalreview
June 26, 2019
Dompé Farmaceutici and Dompé announced the first patient has been enrolled in Study NGF0118, a multicenter, randomized, double-masked, vehicle-controlled, parallel group study to ...
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Reistone Announces First Patient Dosed in Two Phase II Studies of SHR0302
americanpharmaceuticalreview
June 20, 2019
Reistone Biopharma announced dosing of the first patient in their Phase II global clinical trials (RSJ10101 and RSJ10201) of SHR0302 in patients with Ulcerative Colitis and Crohn's disease respectively.
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Arena Announces First Subject Dosed in Etrasimod ELEVATE UC 52 Global Phase 3 Trial
americanpharmaceuticalreview
June 20, 2019
Arena Pharmaceuticals announced the first subject has been dosed in ELEVATE UC 52, the first of two pivotal trials within the Phase 3 ELEVATE UC registrational program evaluating etrasimod 2 mg in subjects with moderately to severely active ulcerative col
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Cellular Biomedicine Announces First Patient Dosing in Anti-CD20 Trial
americanpharmaceuticalreview
June 20, 2019
Cellular Biomedicine Group has initiated its Phase I Clinical Trial of anti-CD20 Chimeric Antigen Receptor T-cell (CAR-T) targeting anti-CD19 treated, relapsed diffuse large B-cell lymphoma (DLBCL) and small B-cell lymphoma patients in China, and dosed th
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First Patient Dosed in Trial of OncoSec's TAVO™, Epacadostat and KEYTRUDA® Combo
americanpharmaceuticalreview
May 24, 2019
OncoSec announced that the first patient has been dosed in TRIFECTA, a triple combination clinical trial of OncoSec's TAVO™, an IDO1 drug (epacadostat) and KEYTRUDA® in patients with unresectable squamous cell carcinoma head and neck (SCCHN) cancer.
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FDA Approves First Anticoagulant for Pediatric Patients to Treat VTE
americanpharmaceuticalreview
May 23, 2019
The U.S. Food and Drug Administration (FDA) has approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older.