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 ...

A new drug application (NDA) has been submitted to the FDA for sunvozertinib in pretreated EGFR exon 20–positive advanced non ...

Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...

A new focus on dermatology, ophthalmology, and gastroenterology will pave ways for many untapped opportunities that Viatris can utilize with its scale and manufacturing power. We believe Viatris is in ...

Hospital Authority says doctors will no longer need to go through two-tier assessment and can apply directly to introduce new drugs from mid-November Hongkongers will have quicker and cheaper access ...

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

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 ...