The U.S. Food and Drug Administration (FDA) has upgraded a recall of tomatoes sold in three southern states to a Class I recall, the most serious level, because the tomatoes may be contaminated ...

A food recall of nearly 6,000 cases of cookies distributed across 15 states has been given the U.S. Food and Drug Administration's (FDA) second-highest risk level. Carley's Inc. voluntarily ...

Enhance your regulatory compliance skills with a comprehensive course on FDA regulations for biologics and drug development. Learn practical applications for ensuring compliance with the FD&C Act ...

Granules India Ltd.'s active pharmaceutical ingredient facility in Telangana received an observation from the US Food and Drugs Administration under Form 483, according to an exchange filing. The FDA ...

FDA approves Yeztugo as the first U.S. twice-yearly injectable for HIV prevention, showing 99.9% efficacy and broad access for all patients.

FDA approves twice-a-year HIV prevention drug that could help end the virus worldwide It reduces transmissions by up to 96%, but now world governments and big-dollar funders will need to step in.

A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug Administration to be used to prevent HIV.

Capricor Therapeutics (NASDAQ: CAPR) received the Orphan Drug designation from the U.S. FDA for its lead cell therapy candidate, Deramiocel, to treat becker muscular dystrophy.

For the new program, the FDA will issue a limited number of ''national priority vouchers'' to companies ''aligned with U.S. national priorities,'' the agency said in a statement.

KalVista has become the latest biotech to face delays to FDA decision-making, as the agency blames a “heavy workload” for pushing back a PDUFA date.

The Halol plant, one of Sun Pharma’s largest manufacturing sites, was last inspected in May 2022. It remains under an import alert after receiving a warning letter from the US FDA. In response to ...