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FDA grants priority review and EMA accepts regulatory submission for Pfizer’s abrocitinib
pharmaceutical-business-review
October 30, 2020
Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib (100mg and 200mg) ...
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Janssen Submits sNDA for Expanded Use of XARELTO
americanpharmaceuticalreview
October 30, 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with ...
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Zydus Cadila receives tentative USFDA approval for Linagliptin Tablets
expresspharma
October 30, 2020
Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor to improve glycemic control in adults with Type 2 diabetes mellitus.
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Enhertu bags US priority review for HER2 gastric cancer
pharmatimes
October 29, 2020
AstraZeneca’s Enhertu has scored a priority review from the US Food and Drug Administration (FDA) for the treatment of HER2-positive metastatic gastric cancer.
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F2G Receives Second FDA Breakthrough Therapy Designation for Olorofim
americanpharmaceuticalreview
October 29, 2020
F2G announced the US Food and Drug Administration (FDA) has granted an additional Breakthrough Therapy Designation to its lead first-in-class candidate, olorofim, for the indication of “Treatment of Central Nervous System (CNS) coccidioidomycosis ...
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AstraZeneca resumes US phase III COVID-19 vaccine trial
pharmatimes
October 29, 2020
AstraZeneca has resumed all clinical trials of its coronavirus vaccine candidate after the Food and Drug Administration (FDA) authorised the restart in the US.
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Trial to evaluate oral nitric oxide therapy in COVID-19 patients
europeanpharmaceuticalreview
October 29, 2020
The study will establish whether NOviricid can improve COVID-19 patient outcomes and survival in 840 recently diagnosed African American patients with comorbidities.
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AstraZeneca gets FDA approval to restart Phase III Covid-19 vaccine trial
pharmaceutical-technology
October 28, 2020
The US Food and Drug Administration (FDA) has authorised the restart of Phase III clinical trial of AstraZeneca and Oxford University’s Covid-19 vaccine candidate, AZD1222, in the country.
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Cannabics Plans pre-IND Meeting Request for Colon Cancer Drug Candidate
americanpharmaceuticalreview
October 28, 2020
Cannabics Pharmaceuticals has signed an agreement with a clinical quality and validation processes consultancy to oversee the preparation and submission of a Pre-IND Meeting request to the FDA on its anti-tumor Drug Candidate CANNABICS™ RCC-33 ...
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GI Supply Gets FDA Clearance for Submucosal Lifting Agent in Pre-filled 10mL Syringe
americanpharmaceuticalreview
October 26, 2020
GI Supply announced the FDA clearance of EverLift™ Submucosal Lifting Agent in a 10mL syringe, a new device for the lift of polyps, adenomas, early-stage cancers and other gastrointestinal lesions prior to excision with a snare or other appropriate ...