#fda

Regeneron says it has secured the first FDA approval for a gene therapy targeting a rare inherited form of hearing loss and plans to offer the treatment free in the United States.

At a House hearing, HHS Secretary Robert F. Kennedy Jr. defended the FDA and Commissioner Marty Makary, framing Makary as an official under heavy pressure from the pharmaceutical industry even as Republicans raised their

A sparse but telling weekly roundup from Endpoints News points to three pressures shaping biotech right now: regulation, clinical momentum, and investor scrutiny.

The FDA plans to convene outside advisers to discuss whether compounding pharmacies should be allowed broader manufacturing access for certain peptides, opening a consequential regulatory debate around supply, oversight,

The FDA is moving closer to naming a new leader for its Center for Biologics Evaluation and Research, according to Endpoints News, a decision with implications for vaccines and biologic regulation.

The FDA has asked Eli Lilly for additional data on its obesity pill Foundayo as the agency evaluates potential risks related to major cardiovascular events and liver damage.

Replimune’s skin cancer therapy has reportedly been rejected by the FDA again, extending a high-profile regulatory setback that had already become a flashpoint in agency debates.

A newly approved daily weight-loss pill moved through U.S. FDA review faster than most drugs in recent years, signaling continued momentum in the obesity treatment market.

The FDA has approved Johnson and Johnson's icotrokinra, branded Icotyde, for moderate-to-severe psoriasis in patients aged 12 and up — a drug the company expects to become a multi-billion dollar blockbuster.

Ipsen is withdrawing Tazverik from the market after a monitoring committee found cases of secondary blood cancers in a confirmatory trial.

Vinay Prasad, a controversial figure at the FDA's biologics center and key ally of Commissioner Makary, is leaving the agency.

The FDA unveils a new retention bonus program aimed at keeping experienced drug reviewers as the agency faces mounting workforce challenges.

Prime Medicine reverses course to seek FDA approval for a previously sidelined rare immune disease therapy, citing the agency's evolving stance on rare diseases.