Social Behavior
BioMarin Appoints New R&D and Business Development Leaders
BioMarin, R&D, Business Development, Leadership, Greg Friberg, James Sabry, Hank Fuchs
FDA Delays Approval of Regeneron’s Multiple Myeloma Drug Due to Manufacturing Issues
Regeneron, linvoseltamab, multiple myeloma, FDA rejection, manufacturing issues, bispecific antibody, cancer treatment
Embracing Agility: Critical for the Role of QARA Professional
QARA Professional, Agility, Quality Assurance, Regulatory Affairs, Market Access, Innovative Therapeutic Solutions, AI, Technology, Regulatory Strategy, Leadership, Communication, Diversity, Inclusion.
FDA’s Rejection of Lykos’ MDMA-Assisted Therapy for PTSD: A Setback but Not a Roadblock for Psychedelic Research
MDMA, PTSD, Lykos Therapeutics, FDA rejection, psychedelic therapy, clinical trials, ethical violations, scientific integrity.
Novo Nordisk’s Wegovy Approved in China: Implications and Future Challenges
Novo Nordisk, Wegovy, semaglutide, obesity treatment, China approval, generic competition, patent expiration, pharmaceutical market
Novo Nordisk’s Once-Weekly Insulin Icodec Faces FDA Rejection and Manufacturing Concerns
Novo Nordisk, icodec, FDA rejection, once-weekly insulin, manufacturing issues, type 1 diabetes, type 2 diabetes, semaglutide, IcoSema
Lykos Faces Significant Setbacks as FDA Rejects MDMA Therapy and Three Studies Are Retracted Due to Unethical Conduct
Lykos Therapeutics, MDMA therapy, FDA rejection, study retractions, unethical conduct, PTSD treatment, psychedelic research
Aldeyra’s Reproxalap Demonstrates Efficacy in Reducing Eye Discomfort in New Phase 3 Study
Aldeyra Therapeutics, Reproxalap, Phase 3 Study, Eye Discomfort, Dry Eye Disease, FDA Rejection
Novo Nordisk Faces Setback in IRA Litigation, Vows to Appeal
Novo Nordisk, IRA lawsuit, Medicare price negotiations, legal setback, appeal
IRA Drug Price Reductions Unlikely to Harm Biotech Innovation, Studies Suggest
Inflation Reduction Act, IRA, drug price negotiations, biotech innovation, Medicare, pharmaceutical industry