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

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.

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

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

Experts who follow these stocks think they can fly higher despite already gaining over 100% since the end of July.

Bristol-Myers Squibb Company ( NYSE: BMY) Morgan Stanley 23rd Annual Global Healthcare Conference September 8, 2025 8:30 AM EDT ...

Trial met primary long episode endpoints with high statistical significance, and RAP-219 was generally well toleratedPatients achieved 77.8% reduction in clinical seizures (p=0.01), with 24% achieving ...

Securing buy-in requires speaking directly to each audience’s priorities—CFOs want payback periods and ROI, CEOs focus on ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from ...

Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative ...