Treatment for Parkinson’s Disease Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277) MARLBOROUGH, Mass.–(BUSINESS WIRE) January 30, 2019 –Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat […]Continue Reading ...
June 19, 2018 Novus Therapeutics, Inc., a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat (ENT), announced receipt of final meeting minutes from the U.S. Food and Drug Administration (FDA) following a Type C meeting held at the Company’s request to discuss its OP-02 development program […]Continue Reading ...
March 2, 2018 Audience: Patient, Health Professional, Risk Manager [Posted 03/02/2018] ISSUE: FDA is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection, that were produced by the company and distributed nationwide. The agency […]Continue Reading ...
By Sally Robertson, BScFebruary 27, 2018 Researchers have uncovered evidence that the reduced sensitivity towards social cues seen in infants with autism spectrum disorder (ASD) hinders the development of certain brain regions during the early stages of development. Credit: Nazarova Mariia/ Shutterstock.com The study suggests that this indifference to social cues such as voices and […]Continue Reading ...
Home › News › FDA Alerts › Bella Diet Capsules by Bella All Natural: Recall – Presence of Sibutramine February 27, 2018 Audience: Consumer [Posted 02/27/2018] ISSUE: Bella All Natural is voluntarily recalling its Diet Capsules labeled as Bella, Lot Number MFD:10.15.2017 EXP: 10.14.2019, to the consumer level. This recall has been initiated due to […]Continue Reading ...
Home › News › FDA Alerts › Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error Preventing Electrical Shock Delivery February 27, 2018 Audience: Risk Manager, Cardiology, Surgery, Patient [Posted 02/27/2018] ISSUE: Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process. […]Continue Reading ...
February 26, 2018 A new study reveals that many patients with breast cancer have misconceptions and fears about radiation therapy, but their actual experiences with modern breast radiation therapy are better than they expected. In the study published early online in CANCER, a peer-reviewed journal of the American Cancer Society, most patients agreed that their […]Continue Reading ...
By Sally Robertson, BScFebruary 26, 2018 Researchers have discovered two distinct groups of short molecules that regulate gene expression in the eyes fluid of people with two different forms of glaucoma. Credit: Thammanoon Khamchalee/Shutterstock.com The differential expression of these microRNAs is important as it could help researchers find more genes that are linked to glaucoma, […]Continue Reading ...
Home › News › Professional › Civilian Prehospital Tourniquets Linked to Reduction in Mortality WEDNESDAY, April 11, 2018 — Civilian prehospital tourniquet application is associated with a six-fold mortality reduction in patients with peripheral vascular injuries, according to a study published in the Journal of the American College of Surgeons. Pedro G.R. Teixeira, M.D., from […]Continue Reading ...
March 1, 2018 A new study conducted by researchers from the University of Bath provides insights into a key protein associated with brain diseases including ALS (motor neurone disease) and dementia. The study observed the ways by which it enters central nervous system cells. The study findings are published in the journal PLOS ONE. Neuronal […]Continue Reading ...
February 27, 2018 A newly developed proactive app could instantly connect breastfeeding mothers with pediatricians or lactation consultants to help collect data, monitor patients and provide consultation and support while improving breastfeeding outcomes for new mothers. Azza Ahmed, an associate professor in Purdue’s School of Nursing, and Jeffrey Brewer, an associate professor of computer and […]Continue Reading ...
Action Points Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal. India dropped the price cap on drug-eluting stents by about 7.6%, to the equivalent of $433.82, Reuters reported. Industry has been pushing for […]Continue Reading ...
The wait for a postoperative pathology report can cause anxiety in cancer surgeons, as well as patients. (ASCO Connection) Almost a third of U.S. military veterans use tobacco, exceeding tobacco-use rates in almost all age groups. (American Cancer Society) A phase III clinical trial of the new-generation gonadotropin-releasing hormone agonist elagolix met the primary endpoint […]Continue Reading ...
The FDA approved the new-generation androgen receptor inhibitor apalutamide (Erleada) for treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). The approval is the first ever for nmCRPC, a condition that had no consensus standard-of-care therapy. As reported at the recent Genitourinary Cancers Symposium, a randomized trial of apalutamide plus androgen deprivation therapy (ADT) showed a 2-year […]Continue Reading ...
Inflammation needs energy An important source for this energy is oxygen, which is indispensable for the cells of the immune system to work properly. Oxygen is an essential element required for cells to survive, but it also adds fuel to the fire of inflammation. Researchers from University of Erlangen-Nuremberg have discovered that the body uses […]Continue Reading ...
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