Rare Disease Experts See Futility in FDA’s Proposed Framework
Critics Warn Plan May Hinder Innovation and Patient Access The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish…
September 2025 Message from WHO’s Vaccine and Immunization Leadership
The fight against misinformation goes to the heart of trust in public health We are at a critical juncture. While best estimates conclude that vaccines have saved more than 150…
EC Approves Henlius and Organon’s Denosumab Biosimilars BILDYOS® and BILPREVDA®
European Commission Grants Approval for Henlius and Organon’s Denosumab Biosimilars BILDYOS® and BILPREVDA® Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced a significant regulatory milestone with the news…
Nuvation Bio Wins MHLW Nod for IBTROZI™ in NSCLC
Nuvation Bio’s IBTROZI™ Wins Regulatory Approval in Japan for Advanced ROS1-Positive Non-Small Cell Lung Cancer Nuvation Bio Inc. (NYSE: NUVB), a global oncology company dedicated to developing novel therapies for…
MindMed Study at Psych Congress 2025 Links GAD to High Suicidal Ideation
MindMed Presents Alarming Data on Suicidal Ideation Among Adults with Generalized Anxiety Disorder at Psych Congress 2025 Researchers from Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), a late-stage clinical biopharmaceutical company…
Merck Gains Two Positive EU CHMP Opinions for KEYTRUDA
Merck Secures Dual Positive CHMP Opinions for KEYTRUDA® in Europe: Subcutaneous Administration and New Head & Neck Cancer Indication Merck (NYSE: MRK), known as MSD outside of the United States…
Celltrion Launches Omlyclo™ Commercially Across Europe at EADV 2025
Celltrion Announces Commercial Availability of Omlyclo™ Across Europe at EADV 2025 Celltrion, Inc. today showcased its longstanding commitment to expanding its biosimilar portfolio in the field of immuno-dermatology by attending…
Layoffs at Six Pharma Companies Could Eliminate Over 39,000 Jobs
Layoffs From Just 6 Pharmas Could Wipe Out Over 39,000 Jobs This year, Novo Nordisk and Merck announced significant layoffs, with Novo planning to axe about 9,000 employees and Merck…
Lexicon Supports Phase III Advancement of Non-Opioid Pain Therapy Following Post-Hoc Analysis
Lexicon Backs Phase III Go Decision for Non-Opioid Pain Med With Post-Hoc AnalysisSupporting Lexicon Pharmaceuticals’ decision to advance the non-opioid analgesic pilavapadin into late-stage development—despite a topline miss in March—is…
Key Challenges in AAD Sourcing: Ensuring GMP Compliance, Reliable Supply, and Quality Control
Key challenges in AAD sourcing: GMP compliance, supply reliability & quality control Amino acid derivatives (AADs) are essential starting materials for solid-phase peptide synthesis, crucial for the development of peptide-based therapeutics…
Intellia Completes Phase 3 HAELO Study Enrollment for Lonvo-z in Hereditary Angioedema
Intellia Therapeutics Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing…
EU Approves Biogen’s ZURZUVAE® as First Treatment for Postpartum Depression
Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC)…