Browsing Tag
European Medicines Agency
91 posts
Asieris puts Cevira Europe launch in Theramex hands as deal tops $250m
Asieris has handed Theramex exclusive Cevira rights across Europe, Australia, New Zealand and Turkey in a deal worth more than $250 million if milestones are achieved, turning a China-approved cervical precancer therapy into a broader international commercialisation test.
Scholar Rock (NASDAQ: SRRK) wins FDA approval for ISEMBYLD in spinal muscular atrophy
Scholar Rock has secured its first U.S. Food and Drug Administration approval with ISEMBYLD, moving from a pre-revenue biotechnology company into commercial execution as analysts model a multibillion-dollar opportunity in spinal muscular atrophy.
Ocugen has FDA alignment and a 2028 filing target. Now OCU410 needs to prove the Phase 2 signal was real
Ocugen starts Phase 3 testing of one-time OCU410 gene therapy for geographic atrophy after a 31% Phase 2 reduction in lesion growth.
AVT80 joins FDA review as Alvotech and Teva target both major Entyvio delivery formats
FDA accepts Alvotech’s AVT80 filing, expanding its Entyvio biosimilar strategy across subcutaneous and intravenous treatment with Teva.
Three-year survival hits 83% as Johnson & Johnson expands TECVAYLI into second-line myeloma
TECVAYLI moves into earlier EU myeloma care after cutting progression risk 83.4%, strengthening Johnson & Johnson’s fast-growing oncology franchise.
REGN rises 3.8% as Pasatru opens a new rare-disease franchise for Regeneron
Pasatru wins FDA approval after cutting new FOP lesions 90%, expanding Regeneron’s rare-disease portfolio as pediatric development approaches.
RESTORE trial could turn NVG-291 into NervGen’s defining spinal cord injury asset
NVG-291 heads into Phase 3 as NervGen deploys its $61m cash runway behind a 150-patient test of hand-function recovery in chronic tetraplegia.
Theriva targets Phase 2/3 VCN-01 trial after early eye-preservation signal
Theriva plans a VCN-01 Phase 2/3 retinoblastoma trial after early eye-preservation signals, but its $11.3m cash runway raises the stakes.
Sutacimig Phase 3 path puts Hemab’s $457.5m post-IPO cash base to work
Sutacimig gets an FDA-backed Phase 3 path as Hemab deploys its $457.5m post-IPO cash base. See what the pivotal trial means for growth.
Neuren Pharmaceuticals (ASX: NEU) lifts 2026 royalty outlook after record DAYBUE quarter
Record DAYBUE sales and rapid adoption of its STIX formulation have strengthened Neuren Pharmaceuticals’ royalty outlook, while Europe and Japan offer the next major tests of the franchise’s global potential.