December 20th 2022
The precision medicine company announced successful completion of its Unyvero urinary tract infection (UTI) clinical trial with promising results and plans for submission to the FDA.
FDA approves IUD to prevent pregnancy for up to 8 years
November 15th 2022The Food and Drug Administration (FDA) has approved Medicine360’s supplemental new drug application to extend the use of its levongestrel-releasing intrauterine system 52mg (LILETTA) to prevent pregnancy for up to 8 years.
Read More
Whooping cough vaccine approved for use during third trimester
October 7th 2022The US Food & Drug Administration approved tetanus toxoid, reduced diptheria toxoid and acellular pertussis vaccine, adsorbed [Tdap] (Boostrix, GSK) today for immunization during the third trimester of pregnancy to prevent pertussis—or whooping cough—in infants under 2 months of age.
Read More
FDA turns down new drug application for oral UTI treatment
June 27th 2022The US Food & Drug Administration (FDA) sent a response letter to Spero Therapeutics regarding its New Drug Application (NDA) for tebipenem pivoxil hydrobromide (tebipenem HBr) to treat complicated UTIs, saying the application lacks sufficient data.
Read More
Evofem Biosciences announces results of post hoc analysis of phase 3 clinical trial data
June 21st 2022Evofem Biosciences, Inc. recently announced results of a post hoc analysis of the registrational Phase 3 AMPOWER trial, which investigated the ability of a contraceptive gel consisting of lactic acid, citric acid, and potassium bitartrate (Phexxi; Evofem) to prevent pregnancy.
Read More
Scynexis submits sNDA for expanded indication of ibrexafungerp tablets
June 8th 2022Currently approved for the treatment of vulvovaginal candidiasis (VVC), and if the sNDA is approved, ibrexafungerp (Brexafemme; Scynexis) would be the first and only oral non-azole medication for the prevention of recurrent VVC.
Read More
FDA accepts Myfembree sNDA for bleeding associated with uterine fibroids
June 2nd 2022The US Food and Drug Administration has accepted to review the supplemental New Drug Application for Myfembree for the potential treatment of heavy menstrual bleeding associated with uterine fibroids for up to 2 years.
Read More
Trastuzumab deruxtecan significantly improves PFS, OS in HER2-low metastatic breast cancer
February 22nd 2022Trastuzumab deruxtecan resulted in a statistically significant improvement in progression-free survival and overall survival compared with physician’s choice of chemotherapy in patients with HER2-low unresectable and/or metastatic breast cancer, irrespective of hormone receptor status, meeting the primary and secondary end points of the phase 3 DESTINY-Breast 04 trial.
Read More
Oral ibrexafungerp for treating acute VVC
February 18th 2022Patients with acute vulvovaginal candidiasis (VVC) greatly benefited from oral ibrexafungerp (Brexafemme, Scynexis), according to results of a global phase 3 randomized, double-blind, placebo-controlled superiority study published in the international journal of obstetrics and gynecology, BJOG.
Read More
Immunotherapy approvals shine light on need for molecular testing in endometrial cancer
February 1st 2022Sarah Lee, MD, MBA, discusses the use of checkpoint inhibitors in endometrial cancer, research regarding the association between MSI-H, dMMR, and TMB-H disease, and the importance of broad molecular testing to ensure all eligible patients are appropriately matched to immunotherapeutic options.
Read More
Relugolix for treating uterine fibroids
January 19th 2022A phase 2, multicenter study has found relugolix (Myfembree; Myovant Sciences) significantly decreases menstrual blood loss in women with uterine leiomyomas and is mostly well tolerated. Relugolix is a small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist.
Read More