Can Seaport’s GlyphAgo overcome agomelatine’s liver problem? New Phase 1 data sharpen the test
Seaport's GlyphAgo shows 6.8-fold higher bioavailability as anxiety trials advance, but its potential to reduce liver risks remains unproven.
Pharma & Biotech
Pharma & Biotech
Affinia presents AFTX-201 preclinical data and UPBEAT trial design at HFSA 2026
Affinia advances AFTX-201 into a 22-patient BAG3 heart gene therapy trial after promising animal results. Human safety and efficacy remain unproven.
Pharma & Biotech
Can Weltruza become Medincell’s next growth driver after Uzedy commercial success?
Medincell gains a second FDA-approved drug as Teva prepares Weltruza's U.S. launch. See the clinical evidence, royalties and commercial outlook.
Pharma & Biotech
NewAmsterdam Pharma and Menarini win EU approval for Ubeslo and Evlarco
NewAmsterdam Pharma Company N.V. and Menarini Group have secured European marketing authorisations for Ubeslo and Evlarco, turning obicetrapib into a commercial-stage cholesterol therapy while leaving PREVAIL to answer the more consequential question of whether its LDL reductions translate into fewer cardiovascular events.
Pharma & Biotech
Roche wins EU approval for Susvimo as wet AMD treatment burden becomes the next battleground
The European Commission has approved Roche’s Susvimo implant for neovascular age-related macular degeneration, offering continuous ranibizumab delivery with refills every six months and creating a fundamentally different alternative to repeated eye injections.
Pharma & Biotech
Johnson & Johnson’s Tecvayli cuts myeloma progression risk 71% as Europe considers much earlier use
European regulators have backed Tecvayli monotherapy after only one prior multiple myeloma treatment, potentially transforming Johnson & Johnson’s BCMA bispecific from a late-line therapy into a much larger second-line franchise.
Pharma & Biotech
Novo Nordisk’s Sogroya moves closer to becoming EU’s first approved treatment for idiopathic short stature
European regulators have backed once-weekly Sogroya for children with idiopathic short stature, potentially giving Novo Nordisk the first EU-approved growth hormone specifically for the condition while expanding a rare-endocrine franchise beyond growth hormone deficiency.
Pharma & Biotech
Merck’s Keytruda-Padcev bladder cancer push moves closer to broader EU approval
Merck & Co.’s Keytruda plus Padcev has won a positive European regulatory opinion for perioperative treatment of resectable muscle-invasive bladder cancer regardless of cisplatin eligibility, potentially expanding an already important oncology franchise into a broader earlier-stage population.
Pharma & Biotech
Roche’s Enspryng gets FDA Priority Review for MOGAD after 68% reduction in relapse risk
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.
Pharma & Biotech
CSL Seqirus Phase 3 influenza vaccine study tests triple-enhancement strategy in older adults
CSL Seqirus’ 7,699-person Phase 3 study supports its enhanced flu-vaccine strategy, though one A/H3N2 comparison missed non-inferiority.