Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...

FDA sets PDUFA Action Date of June 28, 2025 ...

If approved, donidalorsen would be a first-in-class RNA-targeted medicine for hereditary angioedema. The agency’s goal date ...

Former President Donald Trump has boasted in recent months about “Right To Try,” a law he signed in 2018. It’s aimed at ...

A bumper crop of revisions, including a stronger drug benefit, means the plan you enrolled in for 2024 may not be the best ...

If the FDA grants priority review, a decision on the NDA could come within six months after the 60-day filing period.

The US Food and Drug Administration (FDA) has approved Iterum Therapeutics' new drug application (NDA) for ORLYNVAH ...

In a significant move toward enhancing online safety, Dublin has introduced binding rules to protect EU users of video-sharing platforms from harmful content. The new Online Safety Code, set to take ...

01.050 (2)(a), (b) and (c) and C.01.050 (3) of the Food and Drug Regulations. These foreign notification provisions are intended to improve the collection and assessment of new relevant safety ...

The “1+” mechanism for drug registration and approval will be expanded from November to cover all new chemical entities, with a view to giving patients more choices of drugs at lower costs, Secretary ...

an anesthesiologist at New York University Langone Health, tells Inverse. “That is something people worry about all the time.” Perhaps understanding how these drugs work and in what contexts ...