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Pfizer said yesterday that it plans to file for full approval of its COVID-19 vaccine by the FDA later this month — an approval that would allow the companies to market the vaccine directly to consumers and allow the product to stay on the market beyond the pandemic. Read More
The World Health Organization (WHO) has given Moderna’s two-dose COVID vaccine an Emergency Use Listing (EUL), making it eligible for use in the global COVAX initiative aimed at getting vaccines to low- and middle-income countries. Read More
The chief executive officer of troubled Emergent BioSolutions has promised to deliver “within days” the company’s response to a scathing Form 483 issued in April following a serious mix-up of vaccine materials that ruined millions of doses of Johnson & Johnson’s (J&J) COVID-19 vaccine. Read More
AstraZeneca (AZ) reportedly may not file for FDA Emergency Use Authorization (EUA) of its COVID-19 vaccine until mid-May as it needs more time to gather supporting data. Read More
The European Medicines Agency (EMA) is reviewing Eli Lilly’s arthritis drug Olumiant (baricitinib) as a possible treatment for hospitalized COVID-19 patients age 10 years and older who require supplemental oxygen. Read More
Moderna said it plans to produce up to 3 billion doses of its messenger RNA-based COVID-19 vaccine globally in 2022, including booster shots against viral variants and pediatric vaccines. Read More
Operation Quack Hack includes a team of consumer safety officers, special agents and intelligence analysts who triage incoming complaints about fraudulent and unproven medical products. Read More
Deliveries of the J&J vaccine, which were recently paused as the European Medicines Agency investigated the risk of blood clots, are now resuming in Europe with a blood clot warning added to the product information. Read More
Pfizer’s investigational antiviral for treating COVID-19 at home at the first onset of symptoms could become available by the end of this year, said the company’s CEO Albert Bourla. Read More
According to the company, the test offers performance comparable with reverse transcription polymerase chain reaction (RT-PCR) analyses that use nasopharyngeal swabs. Read More
Merck has issued licenses to five Indian generic drugmakers to produce its COVID-19 antiviral molnupiravir in a move to expand global access to the drug. Read More