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Breakthrough Drugs, Big Deals & Public Health Alerts – Biotech and Health News Roundup (Aug 22–23, 2025)

Breakthrough Drugs, Big Deals & Public Health Alerts – Biotech and Health News Roundup (Aug 22–23, 2025)

Regulatory Approvals & Clinical Milestones Pharma & Biotech Industry Moves Startups & Innovation Highlights Medical Research & Innovation Public Health & Policy Developments Sources: Ionis HAE drug approval pharmexec.com biopharmadive.com; BioPharmaDive on Dawnzera pricing and positioning biopharmadive.com biopharmadive.com; AbbVie Rinvoq AA trial via FiercePharma fiercepharma.com; Lancet Neurology SAPPHIRE trial results neurologylive.com neurologylive.com; Reuters – Kite/Gilead’s Interius acquisition reuters.com and Interius press release interiusbio.com; PharmExec on XOMA-Mural deal ts2.tech; Reuters – J&J $2B NC facility and quote ts2.tech ts2.tech; Reuters – Apollo Hospitals stake sale ts2.tech; BiopharmaTrend on Kyorin adopting Elix AI platform biopharmatrend.com biopharmatrend.com; Laotian Times – Amgen Golden Ticket
Revolutionary Medical Breakthroughs of July 2025: Life-Changing Drugs, Diagnostic Wonders & Public Health Milestones

Revolutionary Medical Breakthroughs of July 2025: Life-Changing Drugs, Diagnostic Wonders & Public Health Milestones

On July 2, 2025, the FDA granted accelerated approval to linvoseltamab (Lynozyfic), a BCMA-targeting bispecific antibody, for adults with heavily pretreated relapsed/refractory multiple myeloma, after trials showed a 70% response rate. Also on July 2, 2025, the FDA approved sunvozertinib (Zegfrovy) as the first targeted oral therapy for advanced NSCLC with EGFR exon 20 insertion mutations following chemotherapy. In July 2025, the FDA granted Breakthrough Therapy designation to trastuzumab deruxtecan (T-DXd) plus pertuzumab for HER2-positive metastatic breast cancer. Relutrigine (PRAX-562) received FDA Breakthrough Therapy designation for two rare pediatric epileptic encephalopathies (SCN2A and SCN8A) after a Phase 2 study showed
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