Jenna Payesko

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

The 7-year data showed the median seizure frequency reduction of 75% in those with drug-resistant epilepsy with partial-onset seizures receiving DBS therapy.

Two additional implants are added to the current spine labeling.

The filing is supported by data from MERIT-1 which showed great improvements in pulmonary vascular resistance and 6-minute walk distance versus ongoing background therapy.

This is the first drug in a new class of antiretroviral medications that does not require daily dosing and can greatly provide benefit to patients who have run out of HIV treatment options.

The solution to lower elevated intraocular pressure is approved 2 months ahead of the scheduled PDFUA date.

The investigational drug programs represent a high unmet medical need as there are currently no approved therapeutics targeting the impairment caused by the mutations.

The agency warns that the seizure and bipolar disorder medication can cause hemophagocytic lymphohistiocytosis, a rare but very serious immune system reaction.

Use of the device is appropriate for small- and mid-sized laboratories.

If approved, the same 0.5 mL dose vaccination can be used with all patients ages 6 months and older for whom flu vaccination is recommended.

Data from the 2 clinical trials showed that JYNARQUE slowed kidney function decline in adults at risk of rapidly progressing ADPKD.

Brexanolone received breakthrough therapy designation in September 2016, underscoring the significant unmet need in women suffering from postpartum depression.

A positive PartoSure test was more than 4 times as reliable as a positive fetal fibronectin test, the only other FDA-approved test for assessing the risk of preterm delivery.

Monthly seizures were reduced by about 40% in those taking Epidiolex.

After 3 months, half of the patients reported no substance abuse, while the number of patients using drop to 2 (10%).

Findings indicate that the CD32 molecule is not preferential biomarker to identify HIV silent reservoirs, but instead identifies cells that are actively infected in spite of ART.

Treatment now offers an individualized approach to control bleeding in appropriate patients undergoing surgery.

Transgender/gender-nonconforming youth may present with mental health conditions that require immediate evaluation and implementation gender identity support measures.

Daptomycin for injection is an affordable generic antibiotic alternative to Cubicin.

The device reduces ischemic time in lung transplantation while enabling longer, safe out-of-body time of the allograft.

The findings indicate the potential for a clinically meaningful improvement and stabilization of lung function.

Patients must also receive a brochure and sign risk acknowledgment.

A novel subretinal implantation of a stem cell-based bioengineered patch may restore vision or prevent further vision loss.

Physical and social improvements were observed in the 8-month visit, but importantly, were sustained in the 3-year follow-up period.

Study results showed significant HbA1c reduction when Bydureon was added to insulin glargine therapy versus insulin glargine alone.

The claim that users’ HIV status being shared with 2 other companies calls into question the company's users' privacy policy.

The FDA is requesting that additional clinical trials, along with a bioavailability study, are needed to resubmit ALKS 5461.

When a physician becomes famous, opportunities abound. How can they ensure they’re leveraging the limelight responsibly?

This reduction has the potential to significantly increase HIV transmission at the community level.

The association between long-term antibiotic use and death is especially noticeable while looking at death from heart disease.