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Mar 14, 2026
GSK's RSV vaccine Arexvy received expanded FDA approval to cover all high-risk adults, adding approximately 21 million Americans under 50 to the eligible population and matching competitor approvals from Pfizer and Moderna.
Mar 13, 2026
The FDA launched the Adverse Event Monitoring System (AEMS), consolidating seven legacy databases into a single platform with real-time reporting. The system is expected to save $120 million over five years while improving public access to safety data.
Mar 12, 2026
Researchers are developing personalized treatment approaches for rare and pediatric cancers using genetic profiling, AI-driven dosing, and 3D-printed medications to improve outcomes while reducing long-term toxicity.
Mar 13, 2026
Recent studies examine safety profiles of GLP-1 receptor agonists, finding increased risk for nonscarring hair loss but improved survival in patients with brain metastases and type 2 diabetes.
Mar 13, 2026
The blood-brain barrier continues to block most treatments for glioblastoma and central nervous system diseases, with only 0.01% of biologic drugs reaching the brain. New intellectual property coverage and synthetic methods aim to address delivery challenges.
Mar 13, 2026
The World Health Organization published blueprints for urgently needed antibiotics targeting drug-resistant infections, while CARB-X awarded $1.2 million for novel antibiotic research and the FDA issued guidance on antibiotic duration limits in livestock.
Mar 12, 2026
Cidara Therapeutics is approaching a critical interim analysis of its Phase 3 ANCHOR trial for CD388, an influenza prophylactic candidate. The results will determine whether the company proceeds with its planned Biologics License Application.
Mar 12, 2026
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
Mar 12, 2026
The bipolar depression treatment pipeline includes over 10 therapies from 8+ companies, with recent Phase 3 trials initiated for azetukalner and multiple emerging drugs targeting novel pathways expected to launch by 2036.
Mar 12, 2026
Atara Biotherapeutics announced a Type A meeting with the FDA to discuss the Complete Response Letter for tabelecleucel's Biologics License Application, held by partner Pierre Fabre Pharmaceuticals.
Mar 12, 2026
India's pharmaceutical industry, valued at Rs. 5.41 lakh crore in 2025, is transitioning from a generics powerhouse to an innovation-driven sector focused on biosimilars, complex formulations, and global R&D capabilities.
Mar 12, 2026
BioVersys has dosed the first patient in a Phase 2b trial evaluating alpibectir-ethionamide (AlpE) in combination with first-line TB drugs, following promising Phase 2a results published in the New England Journal of Medicine.
Mar 12, 2026
Brainstorm Cell Therapeutics announced a $1 million private placement at a premium to market price to support its upcoming Phase IIIb trial of NurOwn stem cell therapy for amyotrophic lateral sclerosis.
Mar 12, 2026
The FDA is accelerating its review of daraxonrasib, a targeted therapy for pancreatic cancer, under a new pilot program that could reduce approval time from 10-12 months to one to two months.
Mar 12, 2026
Solid Biosciences has secured FDA alignment on a registration pathway for its Duchenne muscular dystrophy gene therapy SGT-003, with 36 patients dosed to date showing no drug-induced liver injury, myocarditis, or other serious adverse events reported with competing therapies.
Mar 12, 2026
New market reports forecast significant expansion in CAR T-cell therapy, US pharmaceutical drug delivery, and healthcare nanotechnology sectors, driven by chronic disease prevalence and technological advances.
Mar 11, 2026
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
Mar 12, 2026
Pembrolizumab-based regimens demonstrated significant survival improvements in two separate trials: KEYNOTE-B15 for muscle-invasive bladder cancer and KEYNOTE-B96 for platinum-resistant ovarian cancer, with FDA approval granted for the ovarian cancer indication.
Mar 12, 2026
The FDA issued reforms on January 11, 2026, loosening chemistry, manufacturing, and control requirements for cell and gene therapy products to advance innovation and accommodate the unique complexity of these treatments.
Mar 11, 2026
Ascletis Pharma announced positive Phase II results for subcutaneous ASC30 showing 6.3% placebo-adjusted weight loss at 12 weeks, while advancing oral amylin receptor agonist ASC36 toward US FDA IND submission for obesity treatment.
