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The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic
Global Pharma | 10/05/2020 | By Darshana | 330
FDA Continues to Combat Fraudulent COVID-19 Medical Products
Today, the U.S. Food and Drug Administration is providing an update on the agency's efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic
Global Pharma | 08/05/2020 | By Darshana | 381
Cleveland Clinic establishes center for global and emerging pathogens research
Cleveland Clinic is establishing the Center for Global and Emerging Pathogens Research to broaden understanding of emerging pathogens ranging from Zika virus to SARS-CoV-2 (which causes COVID-19) and to expedite critically needed treatments and vaccines
Global Pharma | 04/05/2020 | By Darshana | 384
Revive Therapeutics, a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced that it has received positive feedback from the US Food and Drug Administration (FDA) in response to the company's Pre-Investigational New Drug (pre-IND) meeting
Global Pharma | 25/04/2020 | By Darshana | 813
Detecting iron deficiency early during pregnancy and in young children is crucial. Iron deficiency in children under two years of age can have significant and irreversible effects on brain development. This can lead to negative consequences on learning and school performance later in life
Global Pharma | 22/04/2020 | By Darshana | 353
European regulators issue guidance on regulatory requirements in the context of COVID-19 pandemic
The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients
Global Pharma | 13/04/2020 | By Darshana | 329
Bayer to boost Germany's COVID-19 analysis capacity by several thousand tests per day
Bayer is undertaking further measures to support the fight against the coronavirus pandemic. At various sites in Germany, the company is making available more than 40 virus diagnostics devices from its research operations, enabling Germany's COVID-19 analysis capacity to be increased by several thousand tests daily
Global Pharma | 31/03/2020 | By Darshana | 532
FDA expedites review of diagnostic tests to combat COVID-19
The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA's regulations have not hindered or been a roadblock to the rollout of tests during this pandemic
Global Pharma | 31/03/2020 | By Darshana | 564
Novartis and a consortium of life sciences companies announced an important collaboration to accelerate the development, manufacture and delivery of vaccines, diagnostics, and treatments for COVID-19 in response to the pandemic. The industry brings a range of assets, resources, and expertise needed to identify effective and scalable solutions
Global Pharma | 28/03/2020 | By Darshana | 812
Genentech, a member of the Roche Group, announced the US Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra (tocilizumab) plus standard
Global Pharma | 26/03/2020 | By Darshana | 588
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