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Grace Halsey
Articles
FDA Issues Warning Letters to 6 Companies Marketing Misbranded OTC Topical Analgesics
March 29, 2024
Specifically, the topical analgesics, available over the counter, may contain higher than labeled concentrations of lidocaine, according to the agency.
Moderna Next-Gen mRNA COVID-19 Vaccine Meets Primary Endpoints in NextCOVE Phase 3 Trial
March 27, 2024
The mRNA bivalent vaccine candidate produced a "more robust" immune response vs Spikevax and particularly in adults over the age of 65 years, said Moderna.
Viking Therapeutics Oral Antiobesity Agent Returns Positive Results in Small Study
March 27, 2024
The once daily tablet, VK2375, is headed to a phase 2 trial later this year and is an oral version of Viking's investigational injectable GLP-1/GIP mimetic currently in phase 2.
Steven Nissen, MD, Discusses Historic Bempedoic Acid Labeling for CV Risk Reduction
March 26, 2024
CLEAR Outcomes PI Steven Nissen, MD, links findings from the pivotal trial with labeling updates that make bempedoic acid the only nonstatin agent approved to reduce CV risk.
Sotagliflozin Impact on Stroke, MI to Be Explored in 4 Posters at ACC.24
March 26, 2024
The novel SGLT-2/SGLT-1 inhibitor reduced risk of stroke, MI, and demonstrates significant antiplatelet activity in post-hoc analyses of SCORED phase 3 trial.
Remotely Delivered Lipid Lowering Program Results in Sustained Target LDL-C Levels in High-Risk Population
March 25, 2024
ACC.2024: In a cohort of people at high risk of ASCVD, three-quarters achieved target LDL-C levels at 6 months and 12 months while using a remote algorithm-directed program.
Concomitant SSRI and DOAC Use Increases Risk of Major Bleeding, Including ICH: New Findings
March 25, 2024
Overall, a 33% increased risk of major bleeding was seen, with risk highest during the first 30 days of concomitant use and persistent, but lower, after 6 months.
FDA Approves Fixed-Dose Macitentan/Tadalafil Tablets (Opsynvi) For Pulmonary Arterial Hypertension
March 25, 2024
For the first time, 2 drugs recommended as first line treatment for PAH are combined in a single oral once-daily therapy, which could reduced burden of care.
FDA Expands Bempedoic Acid Label to Include Primary, Secondary CV Risk Reduction, With or Without Statins
March 24, 2024
Bempedoic acid is now the only non-statin therapy indicated for primary CVD prevention, with potential to expand treatment access to millions, said Esperion Therapeutics.
Medicare Will Cover AOM Semaglutide for Cardiovascular Risk Reduction: A First
March 22, 2024
CMS says Medicare Part D plans will cover semaglutide for individuals with overweight/obesity who have preexisting CVD, a first after 40 years of legal prohibition.