PRODUCT
FDA Approves First Engineered T Cell Therapy for Solid Tumors, Expands GSK’s Jemperli
FDA approval, engineered T cell therapy, solid tumors, GSK’s Jemperli, dostarlimab-gxly, afamitresgene autoleucel, Tecelra, endometrial cancer, synovial sarcoma
Bayer’s Kerendia Achieves Primary Endpoint in Phase III Heart Failure Study
Bayer, Kerendia, finerenone, heart failure, cardiovascular outcomes, Phase III study, FINEARTS-HF
Lilly’s Tirzepatide Clears Phase III Cardiovascular Study on Heels of Novo Nordisk’s Semaglutide
Tirzepatide, Lilly, Phase III, Cardiovascular Study, Novo Nordisk, Semaglutide, Heart Failure, Obesity, Weight Loss
AstraZeneca’s Calquence Achieves Significant Progression-Free Survival in Phase III CLL Trial, Eyes Fixed-Duration Approval
AstraZeneca, Calquence, Phase III CLL Trial, Fixed-Duration Approval, Chronic Lymphocytic Leukemia, Progression-Free Survival
Bristol Myers Squibb Resumes Radiopharmaceutical Phase 3 Trial Following Isotope Shortage
Bristol Myers Squibb, Radiopharmaceutical, Phase 3 Trial, Isotope Shortage, RYZ101, Actinium-225
Cognition Therapeutics’ Stock Plummets Following Disappointing Phase 2 Alzheimer’s Trial Results
Cognition Therapeutics, Alzheimer’s disease, Phase 2 trial, stock decline, CT1812, oral treatment, efficacy endpoint
BioMarin’s Brineura Receives Significant Label Expansion from FDA for Children Under 3 with CLN2 Disease
BioMarin, Brineura, FDA, Label Expansion, CLN2 Disease, Children Under 3, Cerliponase Alfa, Intraventricular Injection, Motor Ability Deterioration, Neurodegenerative Symptoms
SEC Staff Recommends Enforcement Action Against Allarity Over Potential Federal Securities Laws Violations
Allarity Therapeutics, SEC, Enforcement Action, Federal Securities Laws, Violations, Wells Notice, FDA, Dovitinib, Stenoparib
Ipsen Licenses Novel Antibody-Drug Conjugate from Foreseen Biotechnology for Cancer Treatment
Ipsen, Foreseen Biotechnology, Antibody-Drug Conjugate (ADC), Cancer Treatment, Global Licensing Agreement, FS001
J&J, Legend’s Phase III Win Cements Carvykti as Earlier-Line Multiple Myeloma Treatment
Carvykti, Multiple Myeloma, Phase III, CARTITUDE-4, FDA Approval, BCMA-Targeted Therapy, Johnson & Johnson, Legend Biotech