Jenna Payesko

A potential first-in-class, oral medication to treat uterine fibroids has been accepted by the FDA.

The resubmitted biologics license application includes data from pivotal phase 3 studies of more than 11,000 patients.

Preliminary results from part 2 of the trial in patients with are expected in the second half of 2019.

The HVAD system is the only approved LVAD approved for implant via thoracotomy or median sternotomy.

Sterile syringe access as part of comprehensive HIV prevention is important to control and prevent outbreaks.

If approved, REMOXY ER will be classified as a schedule II drug and would be subject to strict prescribing and dispensing rules.

If approved, this would be the first oral, 1-dose antiviral and the first medicine with a novel proposed mechanism of action to treat the flu in about 20 years.

The device offers a new treatment option for surgeons managing glaucoma patients’ intraocular pressure.

The authorization of these 2 devices allows for less-invasive vascular access options for patients requiring hemodialysis.

This is the only long-acting local anesthetic to demonstrate significantly reduced postoperative pain and opioid use through 72 hours compared to bupivacaine solution for postoperative pain management.

In the phase 1b trial, one-time administrations of VY-AADC demonstrated robust and durable improvements in patients’ motor function.

The expanded indication provides an important treatment option for clinicians and patients with type 1 diabetes.

NOCDURNA is the first and only sublingual tablet indicated for treatment of nocturia due to nocturnal polyuria in adults awakening at least 2 times per night to urinate.

Clinical data demonstrate that CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina.

The next generation platform measures the eye inside and out to enable highly precise custom laser vision correction.

ContraVir plans to begin a streamlined early clinical program to test the clinical safety and efficacy profile in healthy volunteers and HBV-infected patients.

This is the first study to demonstrate that prescription drugs were often used concurrently, and that polypharmacy was associated with a greater likelihood of experiencing depression.

The panel is intended for use by physicians as an aid for safe and effective pain management.

In both phase 3 studies, bremelanotide met the pre-specified co-primary efficacy endpoints of improvement in desire and decrease in distress associated with low sexual desire.

Risk of antidepressant use decreased as the time after abortion increased.

The submission is backed by an extensive clinical and nonclinical data package comprised of 15 studies.

These are the first FDA Premarket Approved stents for stent-assisted coil embolization.

The cap is the first and only device that kills infection-causing bacteria inside a long-term catheter, preventing contamination.

IMVEXXY is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose.

The zEEG provides clinicians and patients with an EEG system that is simple, easy and convenient that benefits with a quick and smart analysis of data through a cloud platform.

CIMZIA is the first Fc-free biologic of its kind for this patient population.

Findings should prompt future investigations into care disparities at skilled-care facilities to mediate higher mortality rates observed among senior survivors of critical illness.

Of the 246 patients who underwent lung resections, 203 patients had a FEV1 less than 0.8.

Miners who have worked 10 or more years are at greater risk for developing black lung disease and progressive massive fibrosis.

Under Medicaid expansion, declines in ICU admission may mean that increased access to insurance has led to improvements in clinical outcomes.