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Novartis Expands US Manufacturing and R&D with Seventh Facility
Novartis advances its US expansion plan with a seventh facility, including a new API site in North Carolina to enable end-to-end manufacturing and accelerate delivery of innovative medicines.
US FDA Proposes Excluding Semaglutide, Tirzepatide and Liraglutide from 503B Bulks List
The US Food and Drug Administration (FDA) proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, citing no clinical need for compounding these GLP-1 drugs by outsourcing facilities.
OneSource-Backed Generic Semaglutide Secures Health Canada Approval
Orbicular and OneSource Specialty Pharma achieve a major milestone with Canada’s second generic Ozempic approval, strengthening their position in global peptide-based injectable markets.
Addex Therapeutics Reports Promising Preclinical Results for Novel Chronic Cough Therapy
Addex Therapeutics’ experimental GABAB modulator shows potential as a well-tolerated, long-term treatment option for chronic cough, addressing a significant unmet need in idiopathic pulmonary fibrosis patients.
US Food and Drug Administration Clears Expanded Access Pathway for Daraxonrasib
Regulator issues “safe to proceed” letter to Revolution Medicines, enabling early patient access to investigational therapy for advanced pancreatic cancer.
First-in-class therapy approved to treat agitation linked to Alzheimer’s disease, addressing a major unmet need for patients and caregivers.
Emergent BioSolutions Secures Singapore Approval to Expand ACAM2000 Use for Mpox Prevention
Health Sciences Authority clears expanded indication of ACAM2000 for high-risk adults, strengthening preparedness against mpox outbreaks.
Vanda Pharmaceuticals Launches NEREUS (tradipitant) for Motion Sickness in US
Vanda Pharmaceuticals launches NEREUS (tradipitant), the first new motion sickness treatment in over 40 years, now available in the US with direct ordering via nereus.us.
WHO Opens Applications for 2027 Essential Medicines List Update
The World Health Organization (WHO) opens applications for the 2027 update of the Model Lists of Essential Medicines, with submissions accepted until November 6, 2026.
UK MHRA Approves Linerixibat (Lynavoy) for Biliary Disease Itch
The UK Medicines and Healthcare products Regulatory Agency (MHRA) approves linerixibat (lynavoy) for treating itch associated with biliary tract disease, with ongoing monitoring of safety and effectiveness.
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