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Hope Bio Gets FDA Nod to Start First Stem Cell COVID-19 Clinical Trial
contractpharma
April 08, 2020
Autologous mesenchymal stem cells to provide immune support against COVID-19.
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FDA’s CTAP to Expedite COVID-19 Countermeasures
contractpharma
April 08, 2020
New program across public, academic and private sectors aims to expedite the development of life-saving treatments.
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The FDA-approved Drug Ivermectin inhibits the replication of SARS-CoV-2 in vitro
sciencedirect
April 07, 2020
Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARS-CoV-2 able to
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FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors
americanpharmaceuticalreview
April 06, 2020
The U.S. Food and Drug Administration (FDA) approved Sevenfact [coagulation factor VIIa (recombinant)-jncw].
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FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer
americanpharmaceuticalreview
April 06, 2020
The Food and Drug Administration (FDA) has approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
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BGI Receives FDA Authorization for Real-Time SARS-CoV-2 Test
americanpharmaceuticalreview
April 06, 2020
Gilead Sciences has announced that two Phase III studies to test the safety and efficacy of remdesivir in COVID-19 patients have begun.
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Dr Reddy’s recalls four lots of Phytonadione injectable emulsion in US
europeanpharmaceuticalreview
April 06, 2020
The FDA has announced that Dr Reddy’s is recalling Phytonadione injectable emulsion because of complaints due to ampules breaking and shattering.
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Lupin’s Aurangabad Facility Receives EIR from US FDA
expresspharma
April 06, 2020
The inspection for the facility was carried out between February 10, 2020 and February 14, 2020 and concluded with no observations.
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FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic
prnewswire
April 03, 2020
As part of the U.S. Food and Drug Administration's ongoing commitment to fight the Coronavirus Disease 2019 (COVID-19) pandemic, the agency issued guidance for immediate implementation to address the urgent and immediate need.
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Bristol Myers Squibb and bluebird bio submit BLA for Idecabtagene Vicleucel to FDA
pharmaceutical-business-review
April 03, 2020
Bristol Myers Squibb and bluebird bio submitted their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).