FDA Staff Voice Serious Concerns About Investigational ALS Cell Therapy
FDA reviewers voiced serious concerns about the investigational amyotrophic lateral sclerosis (ALS) treatment debamestrocel — mesenchymal stromal cells secreting neurotrophic factors, also known as MSC-NTF, or NurOwn — from BrainStorm Cell Therapeutics ahead of an advisory committee meeting this week. When the FDA first received the drug’s application for approval, it determined the submission was […]
Amoxicillin Alone for Acute Sinusitis Holds Up Against Broad-Spectrum Cousin
Treatment failure with amoxicillin-clavulanate for pediatric acute sinusitis was similar compared with amoxicillin alone, but the broad-spectrum antibiotic may be associated with more adverse events, an examination of a large commercial claims database revealed. The two frequently prescribed antibiotics were similar in their risk for treatment failure (1.7% with amoxicillin-clavulanate vs 1.8% with amoxicillin; RR […]
Early treatment of child obesity is effective
The early treatment of obesity in children is effective in both the short and long term, researchers from Karolinska Institutet report in a study published in The International Journal of Obesity. The researchers followed over 170 young children in Sweden who had received treatment for diagnosed obesity. The children were recruited to the randomised controlled […]
Intensive Pretransplant Consolidation in Older AML Fails to Improve Results
HOUSTON — Intensive consolidation treatment before allogeneic stem-cell transplant did not improve outcomes in older patients with acute myeloid leukemia (AML), a retrospective comparison showed. Relapse-free survival (RFS) at 2 years was virtually identical for patients who received intensive consolidation therapy (51%) and those who did not (50%). The intensive-therapy group had a trend toward […]
Positive Airway Pressure Linked to Less Late-Night Heart Burn Problems
Positive airway pressure (PAP) treatment for obstructive sleep apnea (OSA) was linked to reduced respiratory symptoms and nocturnal gastroesophageal reflux (nGER), an Icelandic study found. After 2 years, full PAP users reported a decrease in both nGER (adjusted odds ratio [aOR] 0.58, 95% CI 0.40-0.86) and wheezing (aOR 0.56, 95% CI 0.35-0.88) compared with non-users, […]
Chatbots Not Always Reliable for Cancer Treatment Advice
Chatbots had mixed results when it came to providing direct-to-patient cancer-related advice and treatment strategies for a wide variety of cancers, according to two studies in JAMA Oncology. When testing GPT-3.5 (OpenAI) with prompts designed to obtain treatment strategies for different kinds of cancers, they found that while most answers were in accordance with National […]
Ultra-Rare Immune System Disease Gets First FDA-Approved Treatment
The FDA approved pozelimab (Veopoz) as the first treatment for adults and children ages 1 year and up with CD55-deficient protein-losing enteropathy. Also known as CHAPLE (complement hyperactivation, angiopathic thrombosis, and protein-losing enteropathy) disease, CD55-deficient protein-losing enteropathy is an inherited disease marked by mutations of the complement regulator CD55 gene, which causes the complement system […]
FDA OKs First Pill for Postpartum Depression
The FDA approved zuranolone (Zurzuvae) as the first oral treatment for postpartum depression, the agency announced late on Friday. Until now, brexanolone (Zulresso) has been the only other treatment with an indication for postpartum depression, but that drug requires a continuous IV infusion administered by a healthcare provider. “Postpartum depression is a serious and potentially […]
Antidepressant Maintenance No Help for Bipolar I Depressive Episode
Continuing adjunctive antidepressant treatment for up to a year following remission of an acute depressive episode in patients with bipolar I disorder showed no significant benefit for preventing relapse, a randomized trial showed. At 52 weeks, 31% of patients treated with maintenance escitalopram (Lexapro) or bupropion XL (Wellbutrin XL) for that duration of time experienced […]
First Treatment Approved for Molluscum Contagiosum
Topical cantharidin (Ycanth) was approved as the first treatment specifically for molluscum contagiosum, the FDA announced. Molluscum contagiosum is a viral skin infection that affects as many as 6 million Americans, mostly children. The approval is to treat adults and pediatric patients as young as 2 years. The new treatment consists of a single-use applicator […]