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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors

Shots:The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) to treat previously treated adults with HER2+ (IHC 3+) unresectable or metastatic solid tumors, who have unsatisfactory alternative treatment optionsMAA was supported by 3 P-II (DESTINY-PanTumor02, DESTINY-CRC02 & DESTINY-Lung01) trials, where DESTINY-PanTumor02 (n=267, incl. 111 HER2+ pts) assessed Enhertu (5.4mg/kg)…
September 11, 2025

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Rhythm Pharmaceuticals
NEWS

Rhythm Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Setmelanotide to Treat Acquired Hypothalamic Obesity

Shots:The US FDA has accepted sNDA of setmelanotide for the treatment of conditions associated with acquired hypothalamic obesity (PDUFA: Dec 20, 2025); Type II variation MAA is under the CHMP’s reviewsNDA & MAA were supported by global P-III (TRANSCEND) trial (N=120) assessing setmelanotide (n=81) vs PBO (n= 39) in 49 adults & 71 pediatric…
August 21, 2025

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