Postpartum depression (PPD), a severe and life-threatening mental illness, affects a staggering number of new mothers, with recent statistics revealing that 1 in 7 new mothers will experience PPD in the 12 months following childbirth. Finally, a new breakthrough treatment option has arrived. The U.S. Food and Drug Administration announced the first-ever oral pill designed … Read more
Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression. Those are just four of the more than 80 pairs of drug names that the Institute for Safe Medication Practices (ISMP) recently … Read more
FDA assigns PDUFA target action date of March 8, 2024 New Drug Application supported by positive Phase III efficacy and safety clinical trial results Milestone builds upon Viatris’ long-standing and continued commitment toward addressing the unmet needs of the MS community PITTSBURGH and NESS ZIONA, Israel, Aug. 7, 2023 /PRNewswire/ — Viatris Inc. (NASDAQ: VTRS), a global … Read more
Approval is based on data from a pivotal clinical trial showing that treatment with LONSURF plus bevacizumab resulted in statistically significant and clinically meaningful improvements in overall survival in patients with previously treated mCRC compared to LONSURF as a single agent PRINCETON, N.J., Aug. 2, 2023 /PRNewswire/ — Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. … Read more
The FDA has approved trifluridine and tipiracil (Lonsurf) plus bevacizumab (Avastin) for patients with metastatic colorectal cancer (mCRC) who were previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; a VEGF inhibitor; and an EGFR inhibitor, if they have RAS wild-type disease.1,2 The regulatory decision is supported by data from the phase 3 SUNLIGHT trial (NCT04737187), … Read more
By The ASCO Post Staff Posted: 8/1/2023 9:22:00 AM Last Updated: 8/1/2023 9:48:24 AM On July 31, the U.S. Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli) with carboplatin and paclitaxel followed by single-agent dostarlimab for patients with primary advanced or recurrent endometrial cancer that is mismatch repairdeficient (dMMR), as determined by an FDA-approved test, … Read more
Estimated read time: 5-6 minutes NEW YORK For Sahar McMahon, having her second baby was a completely different experience than having her first. Her postpartum negative mood, low energy and inability to focus were feelings that she had never felt before. With her first daughter, Ophelia, McMahon downloaded an app to her phone to excitedly … Read more
PARAMUS, N.J., July 26, 2023 /PRNewswire/ — Octapharma USA today announced that Balfaxar (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex) has received U.S. Food and Drug Administration (FDA) approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with … Read more