News

The U.S. FDA has approved coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa) for patients treated with rivaoxaban and apixaban, when reversal of anticoagulation is necessary due to fatal or uncontrolled bleeding.

Andexanet alfa showed a median decrease in anti-Factor Xa activity from baseline of 97% for those on rivaroxaban and 92% for those on apixaban.

An assessment of the burden felt by caregivers of patients with cognitive impairment sought to identify a relationship between the level of burden and the level of impairment.

An initial high dose or high dose escalation can work best for Clostridium difficile treatment.

Dosing of the first patient in the Phase 2 clinical trial of AG10 in patients with ATTR cardiomyopathy, Eidos Therapeutics, Inc. has announced.

This is the first FDA-approved antidepressant for MDD to have data in US Prescribing Information showing a positive effect on processing speed.

All told, 68% of the group receiving a full dose of MDMA no longer qualified for a PTSD diagnosis compared to 29% in the active-placebo control group.

A massive genetic family migraine patient study found more defined risk scores for migraine subtypes.

On Monday, the FDA approved tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who have relapsed or are ineligible for an autologous stem cell transplant (ASCT).

FusionVu allows for the fastest and simplest real-time targeting of prostate biopsies while also providing the highest resolution in real-time guidance for them, according to Exact Imaging.

Orchard Therapeutics announced that its gene therapy candidate, OTL-200, has been granted Rare Pediatric Disease designation for the treatment of metachromatic leukodystrophy.

Researchers examined the role of RPE dysfunction in patients with AMD and found this discovery demonstrated hUTC’s potential therapeutic value in the treatment of AMD.

The discovery could have researchers reconsidering treatment routes for pediatric patients.

The clinically relevant findings suggest that infant passive immunization with second-generation broad and potent bNAbs could be an effective strategy to block mother-to-child HIV transmission.

Despite extended exposure to high doses of estrogen therapy, levels of prolactin did not rise in transgender patients.

The advisory committee did not feel there was substantial evidence regarding the safety and effectiveness of plazomicin for the treatment of bloodstream infections in patients with limited or no treatment options.

The BLA was originally accepted by the FDA for review in September 2017, with the product intended to be used for the treatment of immunological conditions such as rheumatoid arthritis, as well as blood cancers.

Akcea Therapeutics announced that it has expanded its global early access program to the US for its drug volanesorsen, which is in development for treatment of the rare lipid disorder FCS.

The coflex Interlaminar Stabilization disposable instrument kit is a serviceable outpatient set of injection molded instruments provided in a pre-sterilized peel pack for the posterior lumbar motion preservation solution.

The new indication will allow wearers to use the contacts for up to 6 nights and 7 days continuously.

The unique formulation of SUBA-Itraconazole capsules, which has improved bioavailability and significantly reduced variability, represents a substantial innovation.

REGENXBIO Inc. announced that the U.S. FDA has granted Fast Track designation to RGX-131, a novel, one-time investigational treatment for mucopolysaccharidosis type II (MPS II).

A Rare Pediatric Disease designation was granted by the U.S. FDA this morning to Cellectar Biosciences for CLR 131, intended for the treatment of neuroblastoma.

Medication adherence rates struggle in many conditions and diabetes is among the worst of them. Michael Greenfield, MD, discusses 3 ways for clinicians to improve adherence.

The Computed Tomography Angiography device from iSchemaView gives physicians quick, and diverse, options to analyze stroke patient candidates.

If approved, TPOXX would be the first available therapy for smallpox.

The enrollment for the phase 2b DOVE study in VC is completed and the top-line data is expected by July 2018.

Cytokinetics, Incorporated and The ALS Association continue their partnership in an effort to fight ALS.

The technology can be used with both steam and vaporized hydrogen peroxide, simultaneously in any incubation well.

Lyso-Gb1 Identified as most efefctive biomarker for Gaucher disease monitoring.