The approval was based on data from the ongoing Phase 2 CheckMate-142 study which enrolled patients with MSI-H/dMMR metastatic CRC who had received ≥1 prior line of therapy for metastatic disease (N=119).

The sBLA is based on results from the Phase 2 KEYNOTE-224 trial, which enrolled 104 individuals with advanced hepatocellular carcinoma previously treated with sorafenib who were either intolerant to or showed progression of disease after treatment.

Symptoms in patients with short latency include fever, rash, and eosinophilia.

The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use.

More than 1 dose of intravenous acetaminophen on postoperative day 1 was associated with lower opioid utilization (−12.4%) vs non-use, while an even stronger reduction was seen in those receiving more than one oral acetaminophen dose (−22.6%).

For the same 25 cases, a Heat Index screening threshold of 85 degrees Fahrenheit could identify potentially hazardous levels of workplace environmental heat when WBGT was unavailable. Six fatalities occurred when the Heat Index was <91 degrees Fahrenheit.

Precautions should be taken, including wiping down grill after use and inspecting it for wire bristles

For this study, researchers searched several large databases (from 1980 to 2016) for randomized, controlled trials (RCTs) that compared clinical outcomes in patients on DAPT taking PPIs or H2RAs.

Survival no better with second-line pembrolizumab than paclitaxel for gastric, gastro-esophageal cancer

The risk of a nonfatal GI bleeding event was 2.19 per 1,000 person-years in the baseline cohort, 1.77 in the non-high-risk cohort, and 1.61 in the nonmedication cohort.

Cannabidiol is a non-psychoactive component of marijuana that does not cause intoxication or euphoria that comes from tetrahydrocannabinol.

The Warnings and Precautions section for both products has been updated to inform clinicians that there have been reports of false positive urine screening tests for methadone, opiates, and phencyclidine phosphate (PCP) with doxylamine succinate/pyridoxine hydrochloride use.

For this study, researchers identified randomized controlled trials that included adults with moderate-to-severe CD treated with various biologic agents (i.e., infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab) as first- or second-line therapies compared with placebo or an active comparator.

There is a lack of evidence for efficacy of pharmacologic agents and emerging evidence of significant harm; consequently, these agents should be used sparingly, if at all.

The first patient has been enrolled in PEDFIC-1, a phase 3, single, randomized, double-blind, placebo-controlled trial designed to evaluate A4250 in 60 patients (aged 6 months-18 years) with PFIC subtype 1 or 2 who have elevated serum bile acid (sBA) levels and pruritus.

The researchers found that 31% of the patients assigned to bezafibrate had a complete biochemical response (normal levels of total bilirubin, alkaline phosphatase, aminotransferases, and albumin as well as a normal prothrombin index) vs none assigned to placebo.

Noting that infants and children who ingest button batteries can experience esophageal damage leading to significant morbidity and death in as little as 2 hours, researchers from the Children's Hospital of Philadelphia and Nationwide Children's Hospital aimed to identify effective options for mitigating these effects by testing common weakly acidic household beverages, viscous liquids, and sucralfate (Carafate).

The researchers found that the mean DeMeester score was 44 ± 33 for GERD+ and 7 ± 4 for GERD−. For GERD+ and GERD−, the mean HADS scores for anxiety (8 for both; P=0.2) and depression (5 and 6, respectively; P=.3) did not differ significantly.

The new analysis pooled patients from the UNITI-1 and UNITI-2 trials who had clinical response after a single intravenous (IV) dose of ustekinumab and entered a 5-year follow-up period.

The expanded FDA approval was based on results from two 8-week placebo-controlled induction trials and a 52-week maintenance study.

The latest Consensus Guidelines for the Management of PONV (CGM-PONV) recommend an assessment of a patient's baseline risk for PONV using a validated risk score based on independent predictors.

The guidelines were developed by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.

"IMBEDs enable new opportunities for gastrointestinal biomarker discovery and could transform the management and diagnosis of gastrointestinal disease," the authors write.

According to the review, a substantial number of patients can effectively decrease or completely discontinue use of PPIs, as often these agents are prescribed without an appropriate reason.

A Phase 3 clinical trial of patients with travelers' diarrhea demonstrated that Aemcolo was superior to placebo (P=.0008) and non-inferior to ciprofloxacin.

Recalled products include Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir.

The product is a single-use device that delivers hemostatic powder through the channel of an endoscope.

The intravenous formulation combines fosnetupitant (prodrug of netupitant), a substance P/NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist.

The approval of Plenvu was based on multiple clinical trials including the NOCT study which compared Plenvu to the trisulfate bowel cleansing solution Suprep (sodium sulfate, potassium sulfate, magnesium sulfate oral solution; Braintree Laboratories) using a 2-day evening/morning split-dosing regimen.