Bayer’s LYNKUET cut poor sleep reports sharply, but does that make it a menopause sleep treatment?
Bayer's LYNKUET showed improved self-reported sleep quality in a post-hoc Phase 3 analysis. The findings do not establish a separate sleep indication.
Pharma & Biotech
Pharma & Biotech
Mirum’s ATEBRIOZ reduced abnormal bone volume in young children, but will the FDA expand its approval?
Mirum's ATEBRIOZ reduced abnormal bone volume in children aged 6 to under 12 with FOP. Can the results support FDA label expansion in 2027?
Pharma & Biotech
Genmab and Incyte are combining three attacks on KRAS-mutant colorectal cancer, but can they overcome EGFR resistance?
Genmab and Incyte will test petosemtamab with a KRAS G12D inhibitor in metastatic colorectal cancer. Can dual pathway targeting overcome resistance?
Pharma & Biotech
AstraZeneca’s bladder cancer combination cut death risk by 42%, but can it compete with an approved rival regimen?
AstraZeneca's VOLGA trial shows 42% lower death risk with IMFINZI and enfortumab vedotin. Can the regimen compete with approved bladder cancer therapy?
Pharma & Biotech
Pfizer’s new vaccine targets 25 pneumococcal serotypes, but can it outperform PREVNAR 20?
Pfizer's 25-valent pediatric vaccine shows strong Phase 2 immune responses, including against serotype 3. Can Phase 3 establish broader protection?
Pharma & Biotech
Genmab’s Rina-S slashed progression risk by 71%, but can it challenge ovarian cancer treatment standards?
Genmab's Rina-S cut progression risk by 71% and showed an overall survival benefit in Phase 3 ovarian cancer data. What remains before approval?
Pharma & Biotech
Roche and Ionis report 43.1% proteinuria reduction with sefaxersen in Phase 3 IgA nephropathy trial
Roche and Ionis report a 43.1% Phase 3 proteinuria reduction with sefaxersen. Two-year kidney function results remain the next major test.
Pharma & Biotech
Vertex Pharmaceuticals reports new Phase 3 RAINIER data for povetacicept in IgA nephropathy
Vertex's RAINIER trial shows 52% proteinuria reduction with povetacicept ahead of a November 30 FDA decision. Can it stand out in IgA nephropathy?
Pharma & Biotech
Summit Therapeutics partners with Lunit to study AI tumor biomarkers for ivonescimab
Summit Therapeutics and Lunit will study AI-derived tumor biomarkers for ivonescimab, while clinical validation and patient-selection benefits remain unproven.
Pharma & Biotech
Merck and Moderna report 42% lower melanoma recurrence risk in Phase 3 mRNA trial
Merck and Moderna report 42% lower melanoma recurrence risk with intismeran plus Keytruda. Survival, safety and manufacturing remain key.