Paradigm Therapeutics has received its second consecutive Prix Galien USA nomination for SD-101, an investigational whole-body epidermolysis bullosa cream. A new pediatric Phase 3 study offers another opportunity to establish efficacy after the earlier ESSENCE trial failed its primary endpoints.
Abbott’s Libre Duo 10 Day has received FDA De Novo authorization as the first integrated continuous glucose and ketone monitoring system in the United States, potentially extending CGM from daily glucose control into early diabetic ketoacidosis warning.
The FDA has reduced monitoring requirements around the first two Imdelltra doses, lowering an important logistical burden days after Amgen reported positive Phase 3 survival data in first-line extensive-stage small cell lung cancer.
FDA clearance for Medtronic’s LigaSure RAS Maryland instrument adds a familiar vessel-sealing technology to Hugo, strengthening the company’s effort to build a broader robotic surgery ecosystem around instruments, procedures and recurring revenue.
Roche has secured FDA Priority Review for Enspryng in myelin oligodendrocyte glycoprotein antibody-associated disease after Phase 3 data showed a 68% reduction in relapse risk versus placebo.
FDA approval moves Keytruda and Padcev into perioperative MIBC regardless of cisplatin eligibility, intensifying the contest for standard care.
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