Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and older, the companies said Friday. This is the ...

Excitement is building over remdesivir as a treatment for COVID-19. On Friday, the Food and Drug Administration authorized the emergency use of remdesivir to treat COVID-19, President Trump announced.

On Tuesday, September 23, 2025, FDA published guidance titled “Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency.” The guidance, a draft of ...

The FDA has granted fast track designation to an emergency opioid overdose antidote manufactured by OxyContin maker Purdue Pharma, according to MarketWatch. Purdue Pharma said the opioid overdose ...

WASHINGTON -- The US Food and Drug Administration has granted emergency use authorization to the first Covid-19 test that spots chemical compounds associated with the coronavirus in breath, the agency ...

The Food and Drug Administration (FDA) had rescinded emergency use authorizations (EUAs) for COVID-19 vaccines, Health and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday, saying ...

InflaRx had been pursuing development of vilobelimab in other indications beyond COVID, but the company’s hopes for the asset ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...