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Iberdomide, an investigational oral CELMoD therapy, is under FDA review in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma.
US Food and Drug Administration to Drop Two-Study Requirement for New Drug Approvals
The US Food and Drug Administration has announced plans to eliminate its long-standing expectation that new medicines be supported by at least two pivotal clinical trials, signaling a significant shift in regulatory policy aimed at accelerating patient access to innovative therapies.
The global molecular diagnostics market is projected to reach USD 38.01 billion by 2034, according to a new report by Polaris Market Research. The study provides an in-depth assessment of market size, share, emerging trends, and growth forecasts from 2025 to 2034, highlighting the sector’s expanding role in modern healthcare.
Newron Strengthens Clinical Development Funding with Multi-Tranche Share Deal
Newron Pharmaceuticals has secured a staged equity financing agreement worth up to EUR 38 million from a consortium of existing and new investors in Europe and Asia, strengthening its balance sheet as it advances late-stage clinical development of evenamide for treatment-resistant schizophrenia.
Nektar Therapeutics and UCSF collaborate to study TNFR2 agonist NKTR-0165 in multiple sclerosis, aiming to explore its potential for neuroprotection and reduced neurodegeneration.
Simplified once-monthly schedule for RYBREVANT FASPRO matches bi-weekly efficacy, reduces clinic visits and maintains a strong safety profile.
Diakonos Oncology Phase II Glioblastoma Trial Cleared to Continue After DSMB Safety Review
Independent safety review clears Diakonos Oncology’s Phase II DOC1021 glioblastoma trial to proceed, with no safety concerns identified to date.
Duvakitug Shows Durable Efficacy in Ulcerative Colitis and Crohn's Disease in Long-Term Study
Long-term extension data show sustained remission and endoscopic response with duvakitug in ulcerative colitis and Crohn’s disease, strengthening its position as a potential next-generation TL1A therapy.
GSK Wins EU Approval for Exdensur in Severe Asthma and CRSwNP
European Commission clears twice-yearly depemokimab for type 2 inflammation-driven severe asthma and chronic rhinosinusitis with nasal polyps, backed by positive Phase III SWIFT and ANCHOR data.
PCI Reopens Portal for Pharmacy Colleges to File SIF by February 27
Pharmacy Council of India has directed existing pharmacy institutions that missed earlier deadlines to submit their Standard Inspection Format (SIF) for the 2026–27 academic session by February 27, after reopening its online portal.
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