ENTITY
BMS’ KarXT: A Breakthrough in Schizophrenia Treatment with Potential for Alzheimer’s Disease Psychosis
KarXT, schizophrenia, Alzheimer’s disease psychosis, muscarinic receptor agonist, Bristol Myers Squibb, Karuna Therapeutics, FDA approval, novel mechanism of action.
Sarclisa Gains FDA Approval as First-Line Treatment for Newly Diagnosed Multiple Myeloma
Sarclisa, FDA approval, first-line treatment, multiple myeloma, Sanofi, isatuximab, VRd combination therapy.
FDA Approves AstraZeneca’s FluMist as First Self-Administered Flu Vaccine
FluMist, self-administered flu vaccine, FDA approval, AstraZeneca, nasal spray vaccine
Zevra Therapeutics Secures FDA Approval for Miplyffa, a Breakthrough Treatment for Niemann-Pick Disease Type C
Zevra Therapeutics, Miplyffa, FDA Approval, Niemann-Pick Disease Type C, Rare Lysosomal Storage Disorder, Arimoclomol
Eli Lilly and Novo Nordisk Support OAC’s Your Weight Matters Campaign Amidst Competitive Weight Loss Drug Market
Eli Lilly, Novo Nordisk, OAC, Your Weight Matters, weight loss drugs, GLP-1, obesity care, pharmaceutical industry
Sanofi Prepares for Regulatory Submission of Tolebrutinib in Non-Relapsing Secondary Progressive Multiple Sclerosis
Tolebrutinib, BTK inhibitor, Multiple sclerosis, Non-relapsing secondary progressive multiple sclerosis (nrSPMS), Sanofi, HERCULES study, GEMINI 1 and 2 studies, Regulatory approval
Gilead’s Kite Unit Exits China CAR-T Joint Venture with Fosun
Gilead Sciences, Kite Pharma, Fosun Pharma, CAR-T cell therapy, joint venture, China, Yescarta
FDA Approves AstraZeneca’s FluMist as First Self-Administered Flu Vaccine
FluMist, AstraZeneca, FDA, self-administered flu vaccine, nasal spray influenza vaccine, flu prevention, influenza disease, vaccine accessibility
Aligos Therapeutics Reports Positive Phase IIa Results for MASH Treatment, Despite Investor Skepticism
Aligos Therapeutics, MASH (Metabolic Dysfunction-Associated Steatohepatitis), Phase IIa trial, ALG-055009, Liver fat reduction, Investor skepticism, Placebo effect
Navigating Complex Regulatory Landscapes: The Importance of External Support for Biotech Sponsors in IRB, IBC, DMCs, and EACs
Biotech sponsors, IRB (Institutional Review Board), IBC (Institutional Biosafety Committee), DMCs (Data Monitoring Committees), EACs (Ethics Advisory Committees), Regulatory compliance, Clinical trials, Gene therapy research, Risk management