March 21st 2023
Visby Medical has announced its second generation point of care test for detecting sexually transmitted diseases in women has received 510(k) clearance and a CLIA waiver from the FDA.
FDA approves dostarlimab for dMMR endometrial cancer
February 10th 2023The FDA has granted a regular approval to dostarlimab-gxly (Jemperli; GSK) for adult patients with mismatch repair–deficient, recurrent or advanced endometrial cancer that has progressed on or after a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.
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Daré Bioscience announced yesterday that it has received a grant from the Bill & Melinda Gates Foundation of $584,986 to support its efforts related to the development of a vaginal thermosetting gel formulation for the delivery of live biotherapeutics that can be reconstituted at the point of care.
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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.
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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.
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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.
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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.
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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.
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