News

Rivaroxaban (Xarelto) is now indicated to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease.

Palynziq is specifically intended for use by patients with PKU over the age of 18 who have blood Phe levels at or above 600 μmol/L while following their current therapies.

Previously approved in 2015, Stiolto Respimat Inhalation Spray is now indicated for the treatment of COPD including chronic bronchitis and emphysema.

The IMPLANT 2 trial of nolasiban showed a significant increase in the rates of ultrasound-confirmed pregnancy at 10 weeks as well as live births.

In a head-to-head trial, fingolimod (Gilenya) significantly reduced relapses over the course of one year compared to glatiramer acetate (Copaxone), in patients with relapsing-remitting multiple sclerosis.

Novartis files new indication for ranibizumab (Lucentis) for the treatment of retinopathy of prematurity.

The central aims of the study are to better prepare for clinical trials by defining the best outcome measures for assessing how effective prospective therapies in dysferlinopathy are and to gain a stronger understanding of disease progression.

New data from open-label extension studies of ocrelizumab show that patients with relapsing multiple sclerosis and primary progressive multiple sclerosis had better outcomes with earlier treatment.

Being hospitalized a second time for recurrent cases of C difficile created worse outcomes for patients and increased hospital costs.

Research demonstrates that medication-assisted treatment for opioid addiction works, yet few have adopted it.

A new paper details a newly identified and yet-unnamed skeletal disorder with radiographic similarities to—but also unique distinctions from—an extremely rare condition called Jansen metaphyseal chondrodysplasia.

Outcomes can worsen for pregnant women with epilepsy when antiepileptic drug concentrations fall below 65% of preconception amounts.

New study serves as a reminder of how little is known about the clinical and biological manifestations of this form of Huntington's disease.

The application was based on data from the EXPAND phase 3 trial of siponimod in adults with secondary progressive multiple sclerosis.

Recent studies questioned the benefits of second-generation antipsychotics, prompting researchers to reassess the risks of tardive dyskinesia from the use of first- and second-generation antipsychotics.

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

The FDA has approved inotersen (TEGSEDI) for the treatment of adults with the polyneuropathy of hereditary transthyretin-mediated amyloidosis.

The FDA has approved elapegademase-lvlr injection (Revcovi) for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

Originally approved by the FDA in 2006, the vaccine prevents certain cancers and diseases caused by the 9 types of HPV covered by the vaccine—an expansion from its originally-approved prevention of 4 different types.

The FDA has granted an orphan drug designation to MediciNova Inc.’s MN-166, an adjunctive therapy to temozolomide treatment for patients with glioblastoma.

The FDA has granted an orphan drug designation to Eidos Therapeutics, Inc.’s investigational treatment, AG10, for the treatment of transthyretin amyloidosis.

The FDA has approved emicizumab (Hemilbra) for the treatment of hemophilia A without factor VIII inhibitors.

The FDA has approved Genentech’s emicizumab (Hemilbra) for the treatment of hemophilia A without factor VIII inhibitors.

Positive interim clinical data from Genentech’s 2-part pivotal FIREFISH and SUNFISH trials evaluating risdiplam (RG7916), a potential spinal muscular atrophy (SMA) treatment, have been released.

Mount Sinai investigators have found that anti-A4B7 therapy—specifically, vedolizumab—may represent a new therapeutic approach, prompting a couple of phase 1 clinical trials.

This observational data could serve an important role in pharmacoepidemiologic studies that would assess the overall benefit and risks of modern HCV therapies, namely direct-acting antivirals.

Streptococcus pneumoniae, the bacteria primarily behind CABP, is responsible for 1.2 million infections and 7000 deaths in the US annually.

Instances of sexual harassment are associated with high blood pressure and poor sleep for women in midlife, while sexual assault is associated with poor mental health and sleep.