Key Developments

In June 2023, Pfizer Inc., a pharmaceutical company, announced that the DUAVEE (conjugated estrogens/bazedoxifene), an estrogen-based menopause hormone therapy, is back in stock in the U.S., with improved packaging, following a voluntary recall. The recall was due to an issue with the packaging and was not based on any efficacy or safety concerns with the product itself
In June 2023, Pfizer Inc., a pharmaceutical company, and OPKO Health Inc., a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone
In May 2023, Astellas Pharma Inc., a pharmaceutical company, announced that the U.S. Food and drug Administration had approved VEOZAH (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause
In June 2022, Myovant Sciences, a biotech company, and Pfizer Inc., a pharmaceutical and biotechnology company,y announced the U.S. Food and Drug Administration (FDA) had accepted for reviewing a supplemental New Drug Application (sNDA) for MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg). The sNDA proposes updates to MYFEMBREE’s United States Prescribing Information (USPI) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study (RWS) of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years. The U.S. Food and Drug Administration set a target action date of January 29, 2023 for this sNDA under the Prescription Drug User Fee Act (PDUFA). MYFEMBREE was approved in the U.S. in 2021 for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women with a treatment duration of up to 24 months.