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

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

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

After a more than decadelong process to bring the experimental drug elamipretide to market, the treatment’s approval has repeatedly hit roadblocks.

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

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

Shares of Agios Pharmaceuticals AGIO fell 11% on Thursday after the company announced that the FDA had extended the review ...

Australian drug developers have seen a flurry of US Food & Administration (FDA) knockbacks, with the powerful agency either ...

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

Enifer has secured self-affirmed GRAS status for its Pekilo mycoprotein ingredient in the US, and will begin operating a ...

INO-3107's rolling BLA progresses after FDA support despite delays. Priority Review may expedite approval by late 2025. Click here to read my analysis.