The Latest Breaking News from FDA

The FDA cleared Intellia to begin testing its CRISPR gene-editing technology in people on Thursday, leading NTLA stock to jump.

A Biden administration proposal could provide a path to allow statins, birth control and other medications to be accessed over the counter.

The Food and Drug Administration has approved an at-home test that can detect and discern between COVID-19 infection and two strains of the flu, Influenza A and B, continuing the shift from clinical to home-diagnostic care that blossomed during the height of the pandemic.

The agency's action ignores the government's own role in creating a black market in the first place.

The FDA just announced guidance that recommends plant-based alternatives can be labeled as "milk" — for now

Sarepta could snag an accelerated approval for its muscular dystrophy gene therapy, analysts suggested Wednesday as SRPT stock rocketed.

As a Texas federal judge mulls whether to halt the Food and Drug Administration’s longstanding approval of an abortion pill, 12 liberal states have filed a separate lawsuit in a federal district court in Washington state that seeks to force the FDA to drop some restrictions on the drug.

Reata won Food and Drug Administration approval for its neurological disease treatment and RETA stock almost tripled Wednesday.

Pfizer is also facing off with collaborators Sanofi and AstraZeneca Plc to develop prevention for dangerous RSV infections in newborns, a market that could reach $1.5 billion.

Federal health advisers have narrowly backed an experimental vaccine from Pfizer that could become the first shot to protect older adults against the respiratory illness known as RSV

WASHINGTON — Pfizer Inc.’s vaccine for respiratory syncytial virus received endorsement from a key panel of U.S. advisers for its safety in people 60 and older, a key endorsement for the drugmaker’s potential product.