FDA Releases Alert for Amneal and Impax Epinephrine Auto-Injector Device Malfunctions
June 3rd 2020Impax requested that pharmacists who have dispensed Impax’s epinephrine injection, USP auto-injector 0.3 mg since December 20, 2018 contact all patients who received the device and provide instructions for inspection.
Fam-trastuzumab Deruxtecan-nxki for HER2-Positive Unresectable or Metastatic Breast Cancer
May 13th 2020Fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) is indicated for treating adults with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2–based regimens in the setting of metastasis.
Darolutamide for Non-Metastatic Castration-Resistant Prostate Cancer
May 11th 2020In July 2019, the FDA approved darolutamide (Nubeqa, Bayer) for men with prostate cancer that has not spread (ie, nonmetastatic) and no longer responds to medical or surgical treatment that lowers testosterone (ie androgen deprivation therapy).
FDA OKs Dapagliflozin for Heart Failure With Reduced Ejection Fraction
May 6th 2020Officials with the FDA have approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk of cardiovascular death and hospitalization in adults with heart failure with reduced ejection fraction, with and without type 2 diabetes.
FDA OKs Niraparib for Frontline Maintenance Treatment of Ovarian Cancer
April 30th 2020Officials with the FDA approved niraparib (Zejula, GlaxoSmithKline), a once-daily, oral monotherapy, for the first-line maintenance treatment of platinum-responsive advanced ovarian cancer regardless of biomarker status.
Long-Term Data Show Sustained Benefit of Siponimod for Secondary Progressive MS
April 22nd 2020Siponimod (Mayzent, Novartis) had a sustained effect on slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS), according to new long-term data from a phase 3 study.