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AstraZeneca is setting up a new business unit dedicated to overseeing its vaccines and antibody therapies as it looks to rebound from pandemic-era disappointments related to its COVID-19 jab co-developed with Oxford University. Read More
Moderna and the National Institutes of Health (NIH) are in a patent dispute over the company’s messenger RNA (mRNA)-based COVID-19 vaccine developed with the aid of government scientists. Read More
Pfizer and BioNTech are seeking an amended Emergency Use Authorization (EUA) from the FDA allowing their COVID-19 vaccine booster for general use in adults over age 18. Read More
A single dose of Regeneron’s COVID-19 antibody cocktail, REGEN-COV, slashed the risk of contracting the coronavirus by 81.6 percent up to eight months after treatment in a phase 3 trial. Read More
Following a year in which vaccine manufacturing plant Emergent BioSolutions spent many months in the headlines for botching 75 million Johnson & Johnson (J&J) COVID-19 vaccines, the federal government and the troubled company have parted ways. Read More
Pfizer’s investigational antiviral, Paxlovid (07321332 plus ritonavir) cut the risk of COVID-19 associated hospitalizations and death by 89 percent compared to placebo in an interim analysis of a phase 2/3 study, the company announced Friday. Read More
Indonesia, which has a population of more than 273 million, has already granted emergency use approval to the vaccine, to be manufactured by the Serum Institute of India. Read More
Merck’s and Ridgeback Biotherapeutics’ oral COVID-19 medication got its first green light from a regulatory body this week when the UK approved it, making it the first oral antiviral medicine authorized for the treatment of COVID-19. The companies still await authorization from the FDA, which could come early next month. Read More
COVID-19 vaccine makers didn’t undergo pre-approval facility inspections before receiving Emergency Use Authorizations (EUAs) from the FDA for their jabs, the Government Accountability Office (GAO) says. Read More