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The FDA has approved Padcev, a Nectin-4-directed antibody-drug conjugate, plus Keytruda as neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer regardless of cisplatin eligibility, based on Phase III EV-304 data showing a 47% reduction in recurrence risk.

The FDA has granted Regenerative Medicine Advanced Therapy designation to Allocetra, Enlivex's macrophage-reprogramming cell therapy, for age-related symptomatic knee osteoarthritis in patients 64 and older, based on Phase I/IIa data showing durable pain and function improvements.

GSK reports that dostarlimab (Jemperli) monotherapy achieved sustained clinical complete responses in the phase 2 AZUR-1 trial for dMMR/MSI-H locally advanced rectal cancer, with data to be submitted for regulatory review.

Opamtistomig, a PD-L1/4-1BB bispecific antibody from Nanjing Leads Biolabs, has been granted priority review by China's NMPA for advanced extrapulmonary neuroendocrine carcinoma, a rare and aggressive cancer with no globally approved therapy.

The FDA has approved subcutaneous Sarclisa Escena, administered via on-body injector, across all existing multiple myeloma indications for the IV formulation, making isatuximab the first anticancer monoclonal antibody available through both wearable injector and manual subcutaneous administration in the US.

Teva Pharmaceuticals has entered a global licensing agreement with Polpharma Biologics for exclusive commercialization rights to a proposed biosimilar of Ocrevus (ocrelizumab), the CD20-targeted monoclonal antibody used to treat relapsing and primary progressive multiple sclerosis.

Today's BioPharm Brief explores three very different paths toward innovation, from AI-guided precision medicine and a first-in-class autoimmune cell therapy to a late-stage clinical setback in transthyretin amyloid cardiomyopathy.

CARDIO-TTRansform, the largest Phase III trial conducted to date in transthyretin-mediated amyloid cardiomyopathy, did not meet its primary composite endpoint for Wainua (eplontersen), though a monotherapy subgroup showed a nominally significant reduction in cardiovascular events.

Chemomab Therapeutics and Scipher Medicine will merge to advance nebokitug, a first-in-class anti-CCL24 monoclonal antibody, into a precision medicine Phase 2 trial in rheumatoid arthritis guided by Scipher's PrismRA test and AI Network Medicine platform.

As part of BioPharm International's continuing coverage from the BIO International Convention 2026, Sara Jane Demy, CEO of Demy-Colton, discusses how artificial intelligence, global collaboration, and renewed investment could help improve drug development success rates and accelerate innovation.

As part of BioPharm International's continuing coverage from the BIO International Convention 2026, Sara Jane Demy discusses signs of renewed investment activity and why inclusive scientific leadership remains essential to advancing drug development.

Today's BioPharm Brief highlights advances in neurology, hematology, and nephrology, featuring new Alzheimer's disease biomarker data, an expanded pediatric approval for von Willebrand disease prophylaxis, and the first dual BAFF and APRIL inhibitor approved for IgA nephropathy.

Vaccinex will present new biomarker data from the Phase 1b/2 SIGNAL-AD trial of pepinemab — a humanized IgG4 monoclonal antibody targeting Semaphorin 4D — at AAIC 2026 in London on July 13, showing that SEMA4D blockade regulates glial biomarkers associated with disease progression in early Alzheimer's disease, while outlining plans for an enlarged Phase 2b SIGNAL-AD2 study.