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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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FDA Approves Regeneron's Otarmeni: First Gene Therapy for Genetic Hearing Loss Shows 80% Success Rate
Regeneron's Otarmeni becomes first FDA-approved gene therapy for OTOF-related hearing loss, with 80% of patients meeting primary endpoint and 42% achieving normal hearing.
ACRP 2026: Immunology Updates & Parexel Hiring Event
The ACRP 2026 Annual Conference concluded April 23 in Orlando, featuring late-stage immunology trial discussions. Parexel is hosting a clinical research hiring event on April 27 with open coordinator and associate positions.
Generic Drug Forum 2026: Key Takeaways on Market & Regulation
Generic and biosimilar drugs filled 90% of U.S. prescriptions in 2023, saving $445 billion, but manufacturers face razor-thin margins. The FDA's FY2027 budget proposes $9 million in onshoring incentives and global harmonization efforts to strengthen supply chain resilience.
Capricor Therapeutics HOPE-3 Phase 3 Trial Results for Deramiocel in Duchenne Muscular Dystrophy to be Presented at AAN 2026
Capricor Therapeutics announces late-breaking presentation of HOPE-3 Phase 3 trial results for Deramiocel in Duchenne muscular dystrophy at AAN 2026.
CTOC: A New Paradigm in Precision Nutrition and Health Data
CTOC introduces a transformative healthcare model focusing on personalized nutrition and real-world health data integration.
A Secure And Intelligent Drug Delivery Model Integrating Neural Networks With Blockchain
This research proposes a novel drug delivery model that combines neural networks and blockchain technology for personalized healthcare.
Strengths and Limitations of Real-world Data from Electronic Health Records and Claims
This whitepaper discusses the integration of EHR and claims data to enhance research insights in healthcare.
The Gross-to-Net Squeeze: How Physician-Led Patient Education Reduces GTN Erosion
This white paper discusses the gross-to-net challenge in pharma and how patient education can recover net revenue.
The Market for Monoclonal Antibodies: Trends, Challenges, and Opportunities
This study analyzes the monoclonal antibody market, focusing on patent activity, pricing, and market concentration.
BBSW AI Solution Event: Pharma AI's Future Unveiled
The BBSW AI Solution event aims to explore artificial intelligence's transformative role in pharmaceutical research and drug development, though specific event details remain unverified. Industry presentations highlight emerging AI applications in clinical data science and trial automation.
Formycon AG Geschäftsbericht 2025
Annual report detailing Formycon's financial performance and biosimilar development.
Dupixent Becomes First Biologic Approved for Chronic Spontaneous Urticaria in Children Ages 2-11
Sanofi and Regeneron's Dupixent receives FDA approval as first biologic treatment for children with uncontrolled chronic spontaneous urticaria.
OSE Immunotherapeutics' Tedopi Ovarian Cancer Trial Results Selected for ASCO 2026 Presentation
OSE Immunotherapeutics announces TEDOVA Phase 2 trial results for Tedopi in ovarian cancer will be presented at ASCO 2026, marking key milestone for immunotherapy.
Nectero Therapeutics Reports Positive Two-Year Safety Data for EAST System in Abdominal Aortic Aneurysm Trial
Nectero Therapeutics releases two-year safety and efficacy data from first-in-human trial of EAST System for small to medium abdominal aortic aneurysms.
Novo Nordisk's Oral Semaglutide Shows Promise as First GLP-1 Therapy for Children with Type 2 Diabetes
Novo Nordisk's PIONEER TEENS trial demonstrates oral semaglutide significantly reduces blood sugar in children with type 2 diabetes, paving way for regulatory filings.
Neurosterix NTX-253 Schizophrenia Drug Phase 1 Trial on Track for Q2 2026 Completion
Addex spin-out Neurosterix remains on schedule to complete Phase 1 clinical study of NTX-253 for schizophrenia treatment by Q2 2026.
Greenwich LifeSciences GLSI-100 Abstract Accepted at ASCO 2026 for Breast Cancer Immunotherapy Trial
Greenwich LifeSciences announces ASCO 2026 abstract acceptance for GLSI-100, a Fast Track designated immunotherapy in Phase III trials for breast cancer recurrence prevention.
Mabwell's 9MW2821 Becomes First Nectin-4 ADC to Enter Phase III Trial for Triple-Negative Breast Cancer
Mabwell initiates Phase III trial for 9MW2821, the world's first Nectin-4-targeting ADC to reach pivotal testing for triple-negative breast cancer treatment.
ClearPoint Neuro Receives FDA Clearance for Velocity Alpha MR High Speed Surgical Drill System
ClearPoint Neuro announces FDA clearance and first clinical use of its Velocity Alpha MR High Speed Surgical Drill System, expanding drug delivery capabilities.
Vistagen Receives FDA Approval to Advance Refisolone Phase 2 Trial for Menopause Hot Flashes
Vistagen gets FDA clearance to proceed with Phase 2 clinical development of Refisolone, an intranasal treatment for vasomotor symptoms in menopause.