Unsealed emails reveal the role baby-powder maker Johnson & Johnson played in a report that an industry group submitted to U.S. regulators deciding whether to keep warnings off talc-based products linked to cancer. The emails — unsealed in the state …
The U.S. drug regulator on Monday granted full approval to the Pfizer Inc/BioNTech SE COVID-19 vaccine, making it the first to secure such Food and Drug Administration validation as health authorities struggle to win over vaccine skeptics during a relentless …
Bristol Myers Squibb Co. was sued for $6.4 billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp., which the drugmaker bought in 2019. According to a complaint in Manhattan …
Pfizer Inc. and German partner BioNTech SA said on Friday they have started an application process with the U.S. Food and Drug Administration for full approval of their COVID-19 vaccine, currently only authorized for emergency use. If approved, the vaccine …
The U.S. Food and Drug Administration has asked Emergent BioSolutions Inc. to halt producing new materials for COVID-19 vaccines until the regulator completes an inspection of its plant in Baltimore, which is under scrutiny after millions of doses were thrown …
Moderna Inc.’s COVID-19 vaccine appeared to be set for regulatory authorization this week after U.S. Food and Drug Administration staff members did not raise any major new concerns about it in documents released on Tuesday. The FDA reviewers said a …
Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards that their experimental immunisations will be held against, amid a hurried global race to contain the pandemic. The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, in …
The Federal Trade Commission and U.S. Food and Drug Administration (FDA) have warned seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19). The …
People who tried to order medicine online or over the phone have received fake U.S. Food and Drug Administration warning letters instead of the products they bought, in what appears to be an international extortion scam, the agency said on …
Opioid painkillers that have led to thousands of deaths and new drug addicts should be the highest priority of the U.S. Food and Drug Administration, said Scott Gottlieb, President Donald Trump’s pick to lead the agency. “The opioid epidemic in …
