Drug Pipeline News

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.

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.

The rare condition can lead to life-threatening anemia in the fetus and currently lacks FDA-approved treatments.

In this interview, Michael Krychman, MD, a community-based gynecologist in Newport Beach, California, takes a look at 2022 advances within the contraceptive space, as well as looks toward the future.

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.

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.

GSK plc has announced positive results for safety and tolerance of dostarlimab (Jemperli; GSK plc) in treating women with endometrial cancer.

Ibrexafungerp (Brexafemme; Scynexis) is now approved for the treatment of vulvovaginal candidiasis and reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).

This is the first FDA-approved ADC for platinum-resistant disease, according to ImmunoGen.

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.

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.

An advisory panel for the US Food and Drug Administration voted 14-1 to withdraw 17α-hydroxyprogesterone caproate (Makena; Covis Pharma) from the market.

The controversial 17α-hydroxyprogesterone caproate (17-OHPC; Makena) showed to be ineffective at preventing preterm birth, according to briefing documents.

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.

Nkechi Azie, MD, MBA, FIDSA, vice president of clinical development and medical affairs at SCYNEXIS, discusses the potential FDA approval of ibrexafungerp (Brexafemme; SCYNEXIS) for the prevention of recurrent vulvovaginal candidiasis.

After a recent FDA approval, Mirena can be used to prevent pregnancy for up to 8 years.

Novavax joins the growing list of COVID-19 vaccines including vaccines from Pfizer-BioNTech, Moderna, and Johnson & Johnson’s Janssen

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.

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.

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).

ObsEva plans to drop linzagolix, its leading candidate for the treatment of uterine fibroids, following concerns raised by the FDA.

Genevieve Neal-Perry, MD, PhD, sits down with Contemporary OB/GYN to discuss positive data from a recent phase 3 study evaluating fezolinetant (Astellas) for vasomotor symptoms (VMS).

Mycovia Pharmaceuticals recently announced US availability of oteseconazole capsules for the treatment of recurrent vulvovaginal candidiasis in women without reproductive potential.

The CANDLE open-label sub-study enrolled 24 patients with RVVC who failed to respond to fluconazole treatment, which was given as an initial 3-dose treatment over 7 days.

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.

Results suggest the potential of this oral therapy to address the unmet clinical need for long-term medical treatment for endometriosis.

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.

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.

The 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.

Bassem Maximos, MD, MPH, FACOG, discusses 2 recent studies investigating nonhormomal contraceptive gel Phexxi (Evofem Biosciences) for the potential treatment of UTIs and improvement in sexual satisfaction.