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

The Food and Drug Administration (FDA) has approved Tyzavan ™ (vancomycin injection, USP), a novel ready-to-infuse, room temperature stable formulation of vancomycin, for the treatment of various ...

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

Certain words in your Amazon listings can trigger compliance warnings. Understand how to stay accurate while avoiding policy violations.

BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR) has announced an updated timeline for submitting its Biologics ...

The suspended DOH AO significantly increases the regulatory fees obtaining license to operate (LTO) of FDA-regulated establishments, such as drug manufacturers, distributors, pharmacies, as well ...

For companies building FDA-regulated programs, public safety is not just a compliance issue: it's foundational to patient trust, provider confidence and long-term viability.

The Food and Drug Administration (FDA) announced Tuesday it will be moving to take ingestible prescription fluoride products for children off the market, citing concerns that the mineral alters the… ...

The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans laid bare the vaccine skepticism underpinning Robert F. Kennedy Jr.’s new ...

Baby formula, breast milk need to be 'robustly regulated': former FDA commissioner A Consumer Reports investigation found 'concerning levels' of lead and arsenic in some baby formulas Comments ...

NEEDHAM, Mass. — Dr. Todd Ellerin says the compounded pharmacy drugs are regulated on the state level, but most do not possess FDA regulation like brand name drugs ...