Lexicon Receives Complete Response Letter for Sotagliflozin in Type 1 Diabetes and Chronic Kidney Disease
In November 2024, an FDA advisory committee said the benefits of sotagliflozin do not outweigh the risks in adults with type 1 diabetes and chronic kidney disease.
Higher Daily Step Count Linked to Lower Risk for Depression Among Adults
Daily step counts of 5000 or more corresponded with fewer depressive symptoms, according to a recent systematic review and meta-analysis.
FDA Assigns PDUFA Date for TNX-102 SL, a Nonopioid Analgesic for Fibromyalgia
NX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA.
For Alzheimer Agitation, a Novel, Oral NMDA Inhibitor Could be the Next Targeted Treatment
Geriatric psychiatrist and neurocognitive researcher George Grossberg, MD, highlights the mechanism of action for the new dextromethorphan/bupropion combination.
Axsome Completes Phase 3 Clinical Program with AXS-05 in Alzheimer Disease Agitation
Axsome plans to submit a New Drug Application to the FDA in the second half of 2025 that is based on positive results from 4 pivotal phase 3 clinical trails and long-term data.
FDA Approves First Drug for Obstructive Sleep Apnea with Obesity: Daily Dose
Your daily dose of the clinical news you may have missed.
US Adolescent Substance Use Holding Steady or Declining: Highlights from the 2024 Monitoring the Future Survey
Substances of choice used in the previous 12 months were alcohol, nicotine vaping, and cannabis but the trends among the 8th, 10th, and 12th graders are very encouraging.
5 Elemental Facts About Electronic Cigarettes All Clinicians Should Know
The 5 summaries that follow cover harmful ingredients, associated health risks, industry marketing tactics, and current regulatory efforts.
FDA Approves First Generic of Liraglutide Injection to Improve Glycemic Control in Patients with Type 2 Diabetes
The FDA has approved the first generic once-daily GLP-1 injection for the improvement of glycemic control for type 2 diabetes in patients 10 years and up.
New Treatment Approved for Congenital Adrenal Hyperplasia: Daily Dose
FDA Adds Black Box Warning to Fezolinetant Label, Advising of Rare but Serious Liver Injury
The black box warning, the agency's most prominent alert, follows earlier additions to the original fezolinetant label about hepatic injury and regular LFT testing.
FDA Approves Tirzepatide as First Drug for Obstructive Sleep Apnea with Obesity
This marks the second indication for tirzepatide in just more than a year, following its November 2023 approval for adults with obesity or overweight and weight-related medical problems.
Smartphone App Shows Promise for Managing Hypertension in Observational Study
People with hypertension who adhered to the mobile app demonstrated well-controlled blood pressure over a 12-week observational period.
Crinecerfont for Congenital Adrenal Hyperplasia Now Commercially Available, Neurocrine Biosciences Announces
The first in class CRF-1 receptor antagonist allows people with CAH to reduce glucocorticoid doses while androgen levels are maintained or improved.
CagriSema Leads to Weight Reduction of Approximately 23% in Phase 3 REDEFINE 1 Clinical Trial, Short of the 25% Expected
The 22.7% weight loss at 68 weeks places CagriSema essentially on par with, not superior to, competing antiobesity drugs including Lilly's tirzepatide.
Atogepant Improves QoL in Chronic, Episodic Migraine: Daily Dose
Women are at Higher Genetic Risk for PTSD than Men, According to Large Twin-Sibling Study
In the largest twin-sibling study to date of the inherited biological risk of PTSD, researchers found additive genetic and unique environmental effects contributed to the disorder.
Targeted Intervention Boosts Colorectal Cancer Screening Rates among Underserved US Adults
A centralized mailed FIT outreach intervention significantly improved CRC screening in a diverse patient population, according to recent data
Vertex Nonopioid Analgesic on Par with Placebo in Phase 2 Study of Lumbosacral Radiculopathy
Pain relief with suzetrigine was comparable to that seen with placebo, an issue Vertex plans to address with study design as the drug moves to the pivotal phase 3 trials.
Fremanezumab for Prevention of Episodic Migraine in Children: Daily Dose
