The designation was based on data from 7 clinical trials over the past decade, which assessed omalizumab’s efficacy and safety versus various food allergens, such as peanut, milk, and egg.
Officials with the FDA have approved migalastat (Galafold, Amicus Therapeutics), the first oral medication for the treatment of adults with Fabry disease.
Officials with the FDA have approved the first targeted treatment for adult patients with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis, a rare and often fatal disease.
As health care providers work to combat the growing abuse epidemic, the results of a new study suggest that interventions using behavioral insights can change the course of care.
The program recognizes over 30 exceptional pharmacy professionals in 10 categories.
The FDA has approved updates to the labeling for hepatitis C virus (HCV) drug glecaprevir and pibrentasvir (Mavyret) to include new data from 2 clinical studies.
The FDA has approved several strengths of Apotex Inc.’s potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy designation.
Officials with the FDA have approved a new treatment for 2 rare types of non-Hodgkin lymphoma of the skin, relapsed or refractory mycosis fungoides and Sézary syndrome, after at least 1 prior systemic therapy.
Officials with the FDA have updated the label of lumacaftor/ivacaftor (Orkambi, Vertex Pharmaceuticals), approving the treatment’s use in children aged 2 to 5 years old.
The FDA is encouraging the development of novel medication-assisted treatment drugs for individuals with opioid use disorder (OUD), while the first non-opioid medication indicated for the reduction of opioid withdrawal symptoms has been made available to the market.
Each group reported a thrombosis-related adverse event rate of 1.9%.
In a groundbreaking new study, researchers have identified a molecular pathway for stimulating the regeneration of new myelinating cells, and repairing the damage of debilitating neurological diseases.
Earlier in the month, FDA officials announced that several, but not all, drug products containing the active ingredient valsartan, were recalled due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products.
The FDA has approved iobenguane I-131 (Azedra) for adult and pediatric patients aged ≥12 years with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy.
Federal prosecutors are increasingly turning their attention to pharmacies and pharmacists. In this article, we detail some of the recent enforcement efforts, as well as outline some proactive strategies for compliance.
While convenient access to medications certainly aids adherence, and could be facilitated by the Amazon’s recent acquisition of PillPack, the deal stands to disrupt direct pharmacist-to-patient contact, and the essential role of the community-based pharmacist within the healthcare continuum.
The opioid reversal agent Narcan (naloxone) was reportedly used to save singer Demi Lovato’s life after an apparent drug overdose.