Social Behavior
FDA Limits Use of Invivyd’s COVID-19 Prophylactic as New Variants Dominate
Invivyd, COVID-19, Pemgarda, Emergency Use Authorization, FDA, Immunocompromised, Variants
Regeneron Secures EU Approval for Lymphoma Treatment Ordspono Following FDA Rejection
Regeneron, EU approval, lymphoma, bispecific antibody, odronextamab, Ordspono, FDA rejection
FDA Approves Updated COVID-19 Vaccines from Pfizer and Moderna for Enhanced Protection
COVID-19 vaccines, FDA approval, mRNA vaccines, Pfizer, Moderna, updated vaccines, KP.2 variant, JN.1 lineage, emergency use authorization, vaccination guidelines.
FDA Rejects Regeneron’s Blood Cancer Bispecific, Delaying Competition with J&J and Pfizer
Regeneron, FDA rejection, blood cancer bispecific, linvoseltamab, multiple myeloma, J&J, Pfizer
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