The FDA has warned health care providers and patients about the risks of using unauthorized devices for diabetes management, such as continuous glucose monitoring systems (CGMS), insulin pumps and automated insulin dosing systems.
AbbVie has halted enrollment in all ongoing studies of depatuxizumab mafodotin, after an Independent Data Monitoring Committee (IDMC) recommended a phase 3 study of the treatment be stopped due to a lack of survival benefit.
Vitamins and supplements sold at CVS Pharmacy will now go through third party testing to verify the accuracy of the dietary ingredients listed on the packaging and to confirm that the product is free of certain additives.
AliveCor announced that the FDA has cleared a new iteration of their KardiaMobile device, the KardiaMobile 6L, the first 6-lead personal electrocardiogram (ECG) device.
A phase 3 study evaluating the safety and efficacy of relugolix (Myovant Sciences), an investigational oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in combination with estradiol 1.0mg and norethindrone 0.5mg in women with uterine fibroids, met its primary endpoint.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pomalyst (pomalidomide; Celgene) for the treatment of patients with Kaposi sarcoma.
The FDA has cleared the Unity Subcutaneous Delivery System for Remodulin (treprostinil) Injection, also known as the RemUnity system.
The FDA has granted Fast Track designation to Zygel (ZYN002; Zynerba), a cannabidiol gel for the treatment of behavioral symptoms associated with Fragile X syndrome (FXS).
The FDA has granted Fast Track designation to Molgradex (molgramostim; Savara) for the treatment of autoimmune pulmonary alveolar proteinosis.
