News

Stay up to date on the latest product recalls issued by the FDA this past week.

The company’s application for mepolizumab vied for it to serve as an add-on therapy to inhaled corticosteroid-based maintenance treatment in patients with COPD, as guided by patient blood eosinophil counts.

The sublingual film therapy has been approved under a 16 mg/ 4 mg dosage strength for the maintenance treatment of opioid dependence, adding to therapy options which include both brand name and generic versions.

Daniel Ontaneda, MD, provides insight into the implications of discovering a new subtype of multiple sclerosis: myelocortical MS.

Though previous research showed telemonitoring and pharmacist consultation helped patients manage blood pressure for about one year, researchers have been unsure whether it would provide sustained, long-term benefits in at-risk patients.

Deaths due to drug overdoses and suicides have contributed to decreasing US life expectancy, but other factors indicate that there is a deeper root cause driving these trends.

ProQR Therapeutics has announced positive interim results from its phase 1/2 clinical trial evaluating QR-110 as a potential treatment for Leber’s congenital amaurosis 10 (LCA10).

A new study of 4,000 Canadian women with asthma found patients who had higher body mass indices, smoked frequently, and had lower education faced higher risks of developing chronic obstructive pulmonary disease.

With another randomized, controlled trial involving patients at high risk for flu complications currently underway, investigators found that baloxavir may provide an option for patients with uncomplicated influenza.

The CDC reports that, while tobacco use has decreased, cardiovascular disease risk factors and rates of cardiovascular management are still in need of improvement.

The first part of a recent phase 1/2a trial has met its primary objectives, demonstrating safety & tolerability of SYNB1618 in healthy volunteers & identifying a suitable dose to evaluate in patients with PKU.

The FDA has approved the first and only easy-to-swallow thickened riluzole liquid for the treatment of amyotrophic lateral sclerosis.

Bruce Trapp, PhD, discusses his team’s recent discovery of a new subtype of multiple sclerosis: myelocortical MS.

Tiglutik, a thickened liquid suspension of riluzole, was developed to ease administration for patients with amyotrophic lateral sclerosis (ALS) who have difficulty swallowing tablets.

Preliminary findings from WTC Health Program are the first to make the connection among workers at "Ground Zero."

Investigators found 16S rRNA gene qPCR to be more sensitive than culture for detecting C difficile on environmental surfaces.

The FDA has granted an orphan drug designation to Antidote Therapeutics, Inc.’s ATI-1013 for the treatment of Buerger’s disease.

Spinal muscular atrophy patients can see benefits even from late initiation of treatment with the drug nusinersen, according to a new study.

The therapy’s New Drug Application was accepted and granted Priority Review in May of this year, after having been granted Breakthrough Therapy designation in September 2016.

Ticagrelor 60 mg and 90 mg tablets have been indicated for lowering the risk of heart attack, or death from heart attack or stroke in patients with acute coronary syndrome.

The FDA has granted a fast track designation to FCX-013, a gene therapy for the treatment of patients with moderate to severe localized scleroderma.

A recent study found the costs of medical, laser, and surgical interventions were 2.5% or more of the median annual household income for many patients worldwide.

Study of abrupt versus gradual reduction of nicotine informs FDA-proposed rule on reducing cigarette nicotine to "minimally addictive" levels.

Implementation of antimicrobial stewardship programs in outpatient dialysis centers reduce infections caused by multidrug-resistant organisms, including Clostridium difficile.

The FDA has granted a tentative approval to Aquestive Therapeutics, Inc.’s clobazam (Sympazan) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older.

The latest approach to developing a gene therapy for Duchenne muscular dystrophy shows promising results.

More than 2 million US outpatient visits and 3 million emergency department visits from 2005-2009 were accounted to children seeking care for mild TBI. Until now, no evidence-based clinical guidelines for pediatric mild TBI existed.

The FDA has granted a priority review for an anti-PD-1 therapy for the treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

The New Drug Application is based on data from 5 phase 3 studies of the efficacy and safety of esketamine nasal spray for treatment-resistant depression.

The treatment may be most appropriate for toddlers who are admitted to the hospital, have severe allergies, or are seen in the emergency department.