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The U.S. has joined the World Health Organization (WHO)’s Access to COVID-19 Tools (ACT) Accelerator program, a global effort to speed development and production of coronavirus vaccines, treatments and tests, and to help lower-income nations obtain them. Read More
The FDA has unveiled new details on its postmarket safety monitoring of COVID-19 vaccines, including its surveillance for adverse events, that should help vaccine sponsors comply with the agency’s requirements under Emergency Use Authorizations (EUAs). Read More
The World Health Organization (WHO) has issued interim guidance, recommending AstraZeneca’s COVID-19 vaccine for use against the variant first identified in South Africa and for individuals 65 years and older, despite limited supporting data. Read More
The U.S. has secured a hefty supply of COVID-19 monoclonal antibodies, but challenges in administering the potentially game-changing treatments and skepticism around their efficacy have contributed to their minimal use. Now, a newly issued Emergency Use Authorization (EUA) for an antibody combo could inspire greater assurance in the drugs as potential treatments for preventing hospitalization. Read More
After the nasal swab sample is collected using the product’s home collection kit, it must be sent to QDx Pathology’s lab in New Jersey for testing. Read More
Health Canada has approved a labeling change for Pfizer’s COVID-19 vaccine that explains how to extract six doses instead of just five from each vial. Read More
A commonly used asthma medication, AstraZeneca’s Pulmicort (budesonide), was found to significantly reduce COVID-19 symptoms if given within seven days of symptoms appearing, UK researchers reported. Read More
Relief Therapeutics plans to release topline results this month from a phase 2/3 trial evaluating an intravenous formulation of its COVID-19 treatment, RLF-100 (aviptadil). Read More
More than 100 nongovernmental organizations (NGOs) have urged the World Trade Organization (WTO) to extend a waiver of intellectual property rights to help developing nations access COVID-19 treatments and vaccines during the pandemic. Read More
Pfizer said it can cut the time it takes to manufacture its COVID-19 vaccine by almost half from 110 days to an estimated 60 days, a change that should significantly increase the speed of U.S. vaccinations. Read More
Former FDA Commissioner Stephen Hahn is voicing support for making the FDA its own federal agency independent of HHS and for enacting protective measures against political interference. Read More