News

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

Potential PKU treatment receives FDA Fast Track designation.

The therapy met all co-primary and ranked secondary endpoints in the 4 trials without displaying any new safety signals, according to AbbVie.

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.

In the 2 sets of children compared, the odds ratios for ASD were 1.54 and 1.76; and for ADHD were 1.64 and 1.34, respectively.

Data from a duo of poster presentations showed icosapent ethyl reduced potentially atherogenic lipid and inflammatory markers in statin-treated patients with reduced kidney function and high triglycerides.

Evidence has also proven that C. difficile can be found in vegetables.

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

The study showed that 21% of the girls with T2D also had menstrual dysfunction suggestive of polycystic ovarian syndrome.

This morning, Lin BioScience announced that the US FDA has granted orphan drug designation to LBS-007 for the treatment of acute lymphoblastic leukemia (ALL).

Progeria treatment extends survival in children.

The expanded indication was granted based on data from the IMPACT trial, in which it showed superiority to FF/VI and UMEC/VI.

Nusinersen treatment proven to be efficient in spinal muscular atrophy (SMA).

An observational study in Dutch CAPS patients was conducted by Catharina M. Mulders-Manders and colleagues, and results were published in the Orphanet Journal for Rare Diseases.

Prolonged exposure to the over the counter medicine was associated with a 30% increase in the relative risk of ADHD and a 20% increase in the relative risk of ASD.

The committee recommends the approval of baricitinib 2-mg, but not 4-mg; this comes a year after baricitinib was rejected by the FDA.

At the 70th Annual AAN 2018 Annual Meeting, Alnylam announced new results from the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic for the treatment of hATTR amyloidosis.

In total, 35% of all HCPs polled responded that the inhalation device is “highly important” when determining medication for a newly diagnosed, stable patient with COPD.

HIPAA audits force health care organizations to prove they are doing all they can to protect patient data, but there are plenty of other reasons to check those boxes.

The outcomes from the meta-analysis provide strong evidence for the elevated risk of mortality among lung cancer patients with HIV infection.

AbobotulinumtoxinA proves effective across multiple therapeutic uses.

New data proves efficacy of relapsing multiple sclerosis (RMS) treatment.

A result of cooperation between Amerigen Pharmaceuticals and Dipharma, this is the first approved generic equivalent to Actelion Pharmaceuticals’ version of the drug, Zavesca.

The U.S. FDA has cleared the Investigational New Drug application for DTX401 for the treatment of glycogen storage disease type Ia (GSDIa).

This is the first Breakthrough Therapy designation for a MenB vaccine to protect children as young as 1 year of age.

Final approval was given this morning to an Abbreviated New Drug Application for Miglustat 100 mg capsules for the treatment of adult patients with mild to moderate type 1 Gaucher disease.

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

These devices provide additional treatment options for an often-underdiagnosed condition that impacts 12% to 20% of Americans older than 60.

Depressed mothers provided less support to their child, influencing the child’s IQ. The reverse effect, where children’s IQ affected maternal depression, was also seen.

ABO-102, which has previously received rare pediatric disease designation, fast track designation, and orphan drug designation from the U.S. FDA, was the recipient of another acknowledgement this morning when it was granted RMAT designation.