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…
NEWS
Shots:
The US FDA has accepted BLA of ivonescimab + CT for the treatment of EGFR-mutated locally advanced or metastatic non-squamous NSCLC post-TKI therapy (PDUFA: Nov 14, 2026)
BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC who…
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…
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…
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…
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,…
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,…
Shots:
The CHMP has recommended Fylrevy (estetrol/Donesta) as HRT for oestrogen deficiency symptoms in postmenopausal women, both non-hysterectomised (14.2 mg and 18.9 mg) and hysterectomized (18.9 mg); the decision will be anticipated across EEA markets
Fylrevy is an oral estetrol-based oestrogen therapy designed to treat a broad range of oestrogen deficiency symptoms, including VMS, in postmenopausal women
Preclinical and clinical data…
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nChroma Bio has dosed the first patient with CRMA-1001, an epigenetic silencer, in a P-I/II trial for the treatment of hepatitis B virus (HBV) infection
The open-label study is evaluating the safety, tolerability, PK/PD, & efficacy of CRMA-1001 in adults with CHB across single & multiple-ascending dose cohorts, with enrollment ongoing
Additionally, the company…
Shots:
The US FDA has approved Yuvezzi (carbachol & brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, for the treatment of presbyopia in adults; commercially available by Q2’26
Approval was backed by 2 P-III (BRIO I & BRIO II) trials (n>800), with BRIO I showing superior benefit vs individual actives & BRIO II…

