The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed ...

Moderna Inc. said Monday its experimental flu shot showed positive results in a late-stage trial. In a Phase 3 study, the ...

By Denise Mann HealthDay ReporterMONDAY, June 30, 2025 (HealthDay News) — Nestle has joined a growing list of major food ...

The supermarket chain Harris Teeter issued a voluntary recall for a wide variety of ZENSHI sushi products in seven states.

A massive analysis recently published in the journal Aging Cell revealed that rapamycin — the immunosuppressant drug turned longevity darling — delivers almost the same life‑extension benefits as ...

Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

The approved ANDA is for the 20mg/10 ml (2mg/ml) and 50 mg/25 ml (2mg/ml) strength single-dose vials. It is therapeutically ...

Currently, over 80% of its total production is exported to more than 40 countries across Africa, Asia, Europe, and Latin ...

Lenacapavir is regarded as a significant step in improving prevention options for people at risk of HIV infection ...

People who can no longer move or speak may soon have a new option: an implanted device that links their brain to a computer.