News

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.

In a pivotal phase 3 trial, patients' absolute change in facial inflammatory lesion counts included a least squares mean difference of -5.2 compared to those on placebo.

XYOSTED's approval comes nearly a year following Antares first received a Complete Response Letter from the FDA for its application.

The association between moderate hyperbilirubinemia and childhood asthma and lack of association with higher bilirubin levels indicates the association is not causal.

Zinc is the second most abundant trace element in the human body after iron, and is present in high concentration in the human eye.

It’s long been established that obesity can lead to asthma, but new research suggests asthma can also lead to obesity.

Upon finding pH and oxygen may influence how antibiotics perform in CF lung infections, investigators suggest a one-size-fits-all therapy approach may not be the best treatment.

Results from the interim analysis of the ENVISION phase 3 trial shows that givosiran treatment was associated with a statistically significant reduction in urinarly ALA levels in patients with acute intermittent porphyria.

Elbasvir/Grazoprevir has performed well in clinical trials, even among patients with HIV and other coinfections.

The FDA has approved amikacin liposome inhalation suspension (Arikayce) for the treatment of lung disease caused by Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment (refractory disease).

There is a found significant unmet need to develop treatments that limit or protect against scar formation, GA development, retinal thinning, fluid increase, and lesions, as an accompaniment to anti-VEGF therapy.

New data from the CDC suggests young gay and bisexual men are receiving HIV diagnoses at higher rates than their older peers, but it may be due in part to increased testing.

Investigators stressed the importance of culturally competent care for patients with dementia and support for their caregivers.

The robustness of neural responses to positive and negative events may modify adolescent girls’ risk of depression, according to a new study.

The pulmonologist and senior medical advisor, American Lung Association, highlights the necessary steps of smoking cessation practices as well as the unknown surrounding e-cigarettes.

Stay up-to-date on the latest rare disease news by reading the top 5 articles of the week.

The new document will provide guidance on how and when the FDA intends to collect, compile, and publicize retail consignees that may have received recalled foods.

The new formulation, known as Xolair PFS, will be available in the US by the end of the year.