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NEWS

KORU Medical Systems Receives the US FDA Clearance for FreedomEDGE System to Deliver Rystiggo in gMG Patients
Shots: The US FDA has granted 510(k) clearance to FreedomEDGE infusion system to subcutaneously administer Rystiggo (rozanolixizumab-noli) in generalized myasthenia gravis (gMG) patients FreedomEDGE Infusion System enables efficient large-volume SC drug delivery, expanding from home use to clinic-based care to deliver life-changing therapies across various care settings The system supports SC drugs with varying viscosity, flow…
January 30, 2026
NEXTBIOMEDICAL’s Nexsphere-F Receives Health Canada Approval For Musculoskeletal Pain Embolization
Shots: Health Canada has approved Nexsphere-F for the treatment of musculoskeletal pain embolization Nexsphere-F has launched the pivotal RESORB trial in the US post-IDE approval in 126 knee osteoarthritis pts comparing genicular artery embolization vs corticosteroid injections, with enrollment expected to complete in H1’26 Nexsphere-F uses resorbable microsphere tech to temporarily block abnormal blood flow…
January 30, 2026
Repertoire Immune Medicines and Eli Lilly Enter ~$1.9B Deal to Develop Tolerizing Therapies for Autoimmune Diseases
Shots: Repertoire has entered into a strategic collaboration with Eli Lilly to develop tolerizing therapies for multiple autoimmune diseases Repertoire will use its DECODE TCR–epitope discovery platform to identify candidates & lead collaboration activities through nomination, after which Lilly will oversee clinical development, manufacturing, regulatory activities, & commercialization Under the terms, Repertoire will receive $85M…
January 29, 2026
Almirall Reports the NMPA Approval of Seysara to Treat Acne
Shots: The Chinese NMPA has approved Seysara (sarecycline hydrochloride) for the treatment of inflammatory lesions of non-nodular mod. to sev. acne vulgaris in patients (≥9yrs.) Seysara’s efficacy was validated across multiple trials, with real-world evidence from the PROSES study & clinical studies in diverse patient populations in the US & China confirming its relevance across…
January 29, 2026
Seamless Therapeutics and Eli Lilly Forge ~$1.12B Deal to Develop Hearing Loss Therapies
Shots: Seamless has entered into a strategic global research collaboration & licensing deal with Eli Lilly to develop & commercialize programmable recombinase-based therapies for hearing loss using Seamless’ proprietary recombinase platform Under the deal, Seamless will design site-specific recombinases to correct hearing-loss–related gene mutations, while Lilly will receive an exclusive license to advance these programmed…
January 29, 2026
Samsung Bioepis Inks Settlement and Licensing Deal with Regeneron and Bayer for Commercialization of SB15 (Biosimilar, Eylea) 
Shots:  Samsung Bioepis has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of SB15, a biosimilar version of Eylea 2 mg (aflibercept 40 mg/mL solution), in markets excluding the US and Canada   The agreement allows Samsung Bioepis to launch SB15 in the UK from Jan 2026, across the EU from Apr 2026,…
January 29, 2026
Alvotech Inks Settlement and Licensing Deal with Regeneron and Bayer for Worldwide Commercialization for its Biosimilar to Eylea 
  Shots:  Alvotech has signed a settlement and license agreement with Regeneron and Bayer for Eylea 2 mg (aflibercept) biosimilar. With prior US rights effective Q4’26, Alvotech now holds worldwide manufacturing and supply rights for its commercial partners   The settlement enables Alvotech and partners to launch the biosimilar from Jan 1, 2026, in the UK and Canada, May 1, 2026,…
January 29, 2026
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