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FDA Approves Companion Diagnostic to Identify NTRK Fusions in Solid Tumors for Vitrakvi americanpharmaceuticalreview
November 02, 2020
The U.S. Food and Drug Administration (FDA) has approved the next-generation sequencing (NGS)-based FoundationOne CDx test (Foundation Medicine) as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase (NTRK) genes, NTRK1 ...
Kala Pharmaceuticals announces FDA approval of EYSUVIS for short-term treatment of dry eye disease pharmaceutical-business-review
October 30, 2020
Kala Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
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) ...
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 ...
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.
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.
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 ...
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.
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.
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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