The hypertension feature uses data from the Apple Watch’s optical heart sensor to track how a user’s blood vessels respond to heartbeats over 30 days.

The FDA is expected to decide on treatments for acute myeloid leukemia, chronic rhinosinusitis with nasal polyps, and small-cell lung cancer.

The US FDA has added a proposed rule to its spring 2026 agenda that would eliminate the self-affirmed GRAS provision.

Accelerated Approval (AA) pathway, initially established in 1992 during the HIV/AIDS epidemic to provide faster access to ...

Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three ...

FDA launches Rare Disease Evidence Principles to guide therapy reviews, offering new pathways for approval while raising ...

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...

Generative AI, once seen as a tool for writers and artists, is now reshaping the high-stakes world of pharma regulation.

Makary announced plans for a new rare disease pathway in an April episode of "The Megyn Kelly Show." The proposal follows ...

The US FDA has approved two companies’ COVID vaccines that target the latest variant of the virus for adults aged at least 65 years and individuals at high risk for severe outcomes, according to ...

The Food and Drug Administration rescinded the emergency use authorization that made COVID-19 shots available for healthy ...

WASHINGTON (AP) — U.S. regulators approved updated COVID-19 shots Wednesday but limited their use for many Americans — and removed one of the two vaccines available for young children. Additionally, ...