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 cancerFebruary 10th 2023
The 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.
FDA accepts BLA for Sandoz proposed denosumab biosimilarFebruary 6th 2023
The US Food and Drug Administration has accepted the Biologics License Application (BLA) for a proposed biosimilar of denosumab (Prolia and Xgeva; Amgen) for treatment of various conditions.
Scynexis CEO talks recent ibrexafungerp approvalDecember 27th 2022
Marco Taglietti, MD, president and CEO of Scynexis, sits with Contemporary OB/GYN® to discuss the recent approval of ibrexafungerp (Brexafemme) for the reduction in incidence of recurrent vulvovaginal candidiasis.
FDA approves ibrexafungerp for reduction in the incidence of RVVCDecember 1st 2022
Ibrexafungerp (Brexafemme; Scynexis) is now approved for the treatment of vulvovaginal candidiasis and reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).
Dare Bioscience announces grant to develop vaginal thermosetting gel for delivery of live biotherapeuticsNovember 16th 2022
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.
FDA approves IUD to prevent pregnancy for up to 8 yearsNovember 15th 2022
The 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.
FDA advisory panel votes to withdraw approval of premature birth prevention drugOctober 19th 2022
An advisory panel for the US Food and Drug Administration voted 14-1 to withdraw 17α-hydroxyprogesterone caproate (Makena; Covis Pharma) from the market.
Whooping cough vaccine approved for use during third trimesterOctober 7th 2022
The 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.
FDA approves generic cetrorelix acetate injectionAugust 19th 2022
The FDA has approved cetrorelix acetate for injection, a generic version of Cetrotide, for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian stimulation.
FDA approves Myfembree for endometriosis painAugust 5th 2022
Myovant Sciences and Pfizer announces the US Food and Drug Administration has approved Myfembree (relugolix combination tablets) for the once-daily treatment of moderate-to-severe endometriosis-associated pain.
FDA grants ibrexafungerp sNDA priority review for RVVCAugust 2nd 2022
If approved, ibrexafungerp would be the first and only approved therapy for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent vulvovaginal candidiasis (RVVC).
FDA turns down new drug application for oral UTI treatmentJune 27th 2022
The 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.
Evofem Biosciences announces results of post hoc analysis of phase 3 clinical trial dataJune 21st 2022
Evofem 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.
Scynexis submits sNDA for expanded indication of ibrexafungerp tabletsJune 8th 2022
Currently 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.