Drug Pipeline News

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.

Tracy MacNeal, president and CEO of Materna Medical, sits down to discuss the company's recently FDA-cleared Milli Vaginal Dilator for vaginismus and associated dyspareunia, as well as a potential new use for the device currently being studied.

The US Food and Drug Administration has approved oteseconazole (Vivjoa; Mycovia Pharmaceuticals) to reduce the incidence of recurrent vulvovaginal candidiasis.

Pathology expert Mark H. Stoler, MD, discussed the BD Onclarity™ HPV Assay for primary HPV screening and what it means for the future of cervical cancer detection.

These data build upon previous topline results announced in January 2022.

Astellas announced positive data from its study investigating the long-term safety of fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Contemporary OB/GYN® Associate Editor Lindsey Carr sat down with Jessica Shim, MD, an attending at in the Division of Gynecology, Department of Surgery, Boston Children’s Hospital; Harvard Medical School Boston, Massachusetts, to discuss Myfembree (relugolix, estradiol, and norethindrone acetate tablets; Myovant Sciences, Pfizer) and its possible approval in May 2022.

Trastuzumab 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.

Patients 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.

Scynexis released data from its pivotal Phase 3 CANDLE study of oral ibrexafungerp (BREXAFEMME) for the prevention of recurrent vulvovaginal candidiasis.

In this exclusive video interview, Michal Elovitz, MD, chief medical advisor at Mirvie, discusses the latest data from the RNA testing platform in predicting preterm birth at the SMFM 42nd Annual Pregnancy Meeting.