FDA Pushes Back PDUFA Date 3 Months for Tapinarof, 1% Cream for Atopic Dermatitis in Adults and Children
The standard 3-month extension is required by the FDA to review what it considered a "major amendment" to the Organon sNDA, ie, new data from ADORING 3.
Agitation in Alzheimer Disease: A Behavioral Snapshot with Geriatric Psychiatrist George Grossberg, MD
Agitation is the most common disabling neuropsychiatric symptom experienced by individuals with Alzheimer dementia; Grossberg explains how common in this short interview.
Semaglutide May Reduce Alzheimer’s Risk in Adults with T2D: Daily Dose
Your daily dose of the clinical news you may have missed.
The Most Common Bleeding Disorder in Your Patients Could be Hiding in Plain Sight
von Willebrand disease affects up to 1% of the population yet diagnosis is delayed an average of 16 years after onset of symptoms, especially in women.
Semaglutide 2.4 mg Reduces Risk for Hospitalization for Any Cause in Adults with CVD, Obesity
ObesityWeek 2024. Semaglutide 2.4 mg reduces rates of composite CV outcomes in high-risk patients without diabetes and now is shown to reduce inpatient care and length of stay.
ObesityWeek 2024: Viking Therapeutics Presents New Positive Data from VK2735 Obesity Program
Results from the VENTURE phase 2 trial and a phase I oral formulation study found that VK2735, a dual GLP-1 and GIP receptor agonist, demonstrated promise in treating obesity.
Semaglutide 2.4 mg: Shows Superior Improvement in Liver Fibrosis, MASH Resolution in Pivotal Phase 3 Trial
Novo Nordisk announced the topline findings from the pivotal ESSENCE trial and intends to file applications in early 2025 with US and EU regulators.
The RSV Vaccine Population was Narrowed for Good Reason, says Robert Hopkins, Jr, MD, Medical Director of the NFID
ACIP recommendations for the most appropriate older population for the RSV vaccine has shifted and the NFID medical director explains why.
Metabolic Bariatric Surgery Takes a Backseat as GLP-1RA Use Soars, According to New Research
Clinicians should continue to monitor trade-offs between pharmacologic and surgical management of obesity, researchers said.
FDA Approves New Treatment for Uncomplicated UTIs: Daily Dose
GoodRx, Opill Team Up on OTC Delivery Program for Contraceptive
The new e-commerce partnership expands access to Opill by allowing direct delivery of the contraceptive to consumers' homes without a prescription.
Eisai Announces Completion of Rolling BLA for SQ Autoinjector-Delivered Lecanemab
The autoinjector delivers a weekly maintenance dose of 360 mg lecanemab for individuals who have completed biweekly treatment initiation by IV infusion.
Sotagliflozin Setback: Cautionary FDA AdComm Vote Reflects Continued Concern for Negative Risk/Benefit Ratio in T1D with CKD
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 against recommending the SGLT1/SLGT2 inhibitor to treat adults with T1D and CKD.
Dermatologist Mona Shahriari, MD, Talks Nonsteroidal Topicals for Atopic Dermatitis
There are 3 classes of nonsteroidal topical therapies for atopic dermatitis that target the specific underlying pathophysiology of the skin disease. Shahriari provides a primer.
Oral Semaglutide Linked to Lower Risk of MACE: Daily Dose
Greatest Increase in Mortality from Early-Onset Colorectal Cancer Seen Among Youngest US Adults
ACG: Mortality associated with both early- and late-stage EO-CRC rose most significantly among young adults aged 20 to 44 years between 2000 and 2022, new research reveals.
Worst States for Health Care in the US: 2024
Get a quick look at the US worst states for health care ranked using a composite score that included measures of cost, access, and outcomes.
GLP-1RAs Reduce the Risk of Early-Onset Colorectal Cancer in Adults with T2D
ACG 2024: New study results indicate GLP-1 RAs have a potentially protective role to play in combating EO-CRC, the incidence of which is notably rising worldwide.
New Phase 3 Data Suggest Benefits of Early Lecanemab Initiation on Alzheimer Disease Progression, Support Long-Term Safety
New data from phase 3 Clarity AD OLE trial show sustained treatment benefit among participants with low baseline tau and brain amyloid with no new safety signals.
Roche Amyloid Plasma Panel for Alzheimer Disease Demonstrates Negative Predictive Value of 96%, Company Announced
CATD 2024: The Elecsys plasma panel also demonstrated high sensitivity and specificity for AD, building strong evidence for streamlined early disease detection.