News

The application seeks approval of giredestrant as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I to III breast

The regulator granted the application priority review for this indication, assigning a Prescription Drug User Fee Act (PDUFA) date of 30 September 2026. Camzyos is currently approved for

The value includes a $1.55bn upfront payment and as much as $1.1bn in regulatory and commercial milestone payments. The acquisition aligns with Servier’s strategic goal in rare neurology,

The agreement covers Hanmi’s candidate that uses its LAPSCOVERY long-acting platform technology. Sonefpeglutide combines Hanmi’s proprietary technology and has previously achieved approval from the US Food and Drug

This marks the first approved immunotherapy combination for this patient segment in the US. The approval relies on positive data from the POTOMAC Phase III trial, which was

The agreement covers antibody-drug conjugates with new payloads and multi-specific antibodies featuring distinct immune-engaging mechanisms. The portfolio consists of eight drug candidates originating from Innovent Biologics and four

If approved, venglustat would be the first treatment in the US to address the neurological symptoms of GD3, which currently have no targeted therapies. The decision is anticipated

Elunetirom is an oral, once daily, brain-penetrant CNS thyroid hormone receptor (CNS-TR) agonist in development for bipolar depression and major depressive disorder (MDD). The therapy is intended as

This move strengthens vaccine supply resilience in Colombia and creates a pathway for SK bioscience’s expansion into Latin America. The Colombian Ministry of Health and Social Protection, National