United States Food and Drug Administration
Eisai Seeks FDA Approval for Monthly IV Dosing of LEQEMBI for Alzheimer’s Disease Treatment
LEQEMBI, Eisai, FDA, Alzheimer’s disease, monthly IV dosing, subcutaneous autoinjector, lecanemab-irmb, Biogen
GSK’s RSV Vaccine Wins Expected Expansion into At-Risk Adults Aged 50-59
GSK, RSV vaccine, Arexvy, FDA approval, adults aged 50-59, increased risk, respiratory syncytial virus, lower respiratory tract disease, medical conditions, chronic obstructive pulmonary disease, asthma, heart failure, diabetes.
FDA Expands Approval of GSK’s RSV Vaccine to Include At-Risk Adults Aged 50-59
RSV vaccine, GSK, FDA approval, at-risk adults, respiratory syncytial virus, Arexvy
Biomea’s Early-Stage Diabetes Drug Placed on Full Clinical Hold, Stock Plummets
Biomea, diabetes, clinical hold, FDA, BMF-219, liver toxicity, stock crash
Geron’s Rytelo Receives FDA Approval for Lower-Risk Myelodysplastic Syndromes Treatment
Geron, Rytelo, FDA Approval, Blood Cancer, Myelodysplastic Syndromes, Telomerase Inhibitor, Imetelstat
Moon Surgical’s Maestro Robotic Laparoscopy Platform Receives FDA Clearance for Commercial Use
Moon Surgical, Maestro, Robotic Laparoscopy, FDA Clearance, Commercial Use, Surgical Innovation
Bristol Myers’ KRAS Confirmatory Data Avoid Amgen’s Flaws but Leave FDA Prospect Unclear
Bristol Myers Squibb, KRAS confirmatory data, Amgen, FDA, accelerated approval pathway, oncology therapies, clinical benefits, confirmatory trials
Jazz Pharmaceuticals Presents Groundbreaking HER2 Biliary Tract Cancer Data Ahead of FDA Decision
Jazz Pharmaceuticals, HER2, Biliary Tract Cancer, FDA Decision, Zanidatamab, Priority Review
Moderna and Merck’s Cancer Vaccine Shows Promising Results in Combination with Keytruda
Moderna, Merck, Cancer Vaccine, Keytruda, Melanoma, mRNA Technology, ASCO, FDA, Rare Disease, START Pilot Program
FDA’s Operation Warp Speed for Rare Diseases: First Five Participants Announced
FDA, Operation Warp Speed, Rare Diseases, START Program, Gene Therapies, Neurodegenerative Conditions