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…
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…
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’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 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 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 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 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 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: 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 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…
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)…