Uterine Fibroids
📧 Sign up to get email alerts when something new happens for Uterine Fibroids.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2023-02-28FDA Approved: LUTRATE DEPOT — Supplemental Application (Avyxa Pharma, LLC)
The FDA approved a supplemental application for LUTRATE DEPOT (leuprolide acetate) submitted by Avyxa Pharma, LLC.
-
FDA label_change · 2022-08-05FDA Approved: MYFEMBREE — Supplemental Application (Sumitomo Pharma America, Inc)
FDA approved a supplemental application for MYFEMBREE (relugolix, estradiol hemihydrate, and norethindrone acetate) from Sumitomo Pharma Ame…
-
CLINICAL_TRIALS trial_result · 2022-07-08Clinical Trial Update: A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding [Phase 3]
Phase 3 trial assessing safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding; study ter…
-
FDA approval · 2022-06-06FDA Approved: LEUPROLIDE ACETATE — Original Application (Eugia US LLC)
The FDA approved Eugia US LLC's generic Leuprolide Acetate under an Original Application (ANDA 212963), making a generic version of this med…
-
CLINICAL_TRIALS trial_result · 2022-04-20Clinical Trial Update: LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids [Phase 3]
Phase 3 trial update for relugolix in women with heavy menstrual bleeding due to uterine fibroids completed with results posted.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS trial_result · 2022-04-19Clinical Trial Update: LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids [Phase 3]
Phase 3 trial update on relugolix for heavy menstrual bleeding due to uterine fibroids completed with results posted.
-
CLINICAL_TRIALS trial_result · 2022-04-06Clinical Trial Update: Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy [Phase 4]
Phase 4 clinical trial evaluating intraoperative carbetocin to reduce blood loss during hysteroscopic myomectomy has completed.
-
CLINICAL_TRIALS trial_result · 2022-03-31Clinical Trial Update: A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women [Phase 4]
Phase 4 trial assessing safety and efficacy of elagolix for heavy menstrual bleeding linked to uterine fibroids in premenopausal women has c…
-
CLINICAL_TRIALS trial_result · 2021-12-08Clinical Trial Update: Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids [Phase 4]
Phase 4 clinical trial update on treatment for heavy menstrual bleeding in women with uterine fibroids; results posted in 2021.
-
CLINICAL_TRIALS trial_result · 2021-11-05Clinical Trial Update: Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy [Phase 3]
Phase 3 trial evaluating rectal misoprostol to reduce intra-operative blood loss during myomectomy has completed.
-
CLINICAL_TRIALS trial_result · 2021-08-26Clinical Trial Update: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids [Phase 3]
A Phase 3 trial evaluating vilaprisan for uterine fibroids was terminated, with results posted in 2021.
-
FDA approval · 2021-08-13FDA Approved: LEUPROLIDE ACETATE — Original Application (NorthStar RxLLC)
FDA approved the Leuprolide acetate original application (ANDA213829) for a generic version, issued to NorthStar RxLLC.
-
FDA label_change · 2021-08-02FDA Approved: ORIAHNN — Supplemental Application (AbbVie Inc.)
FDA supplemental application for ORIAHNN (elagolix with estradiol and norethindrone) from AbbVie Inc. seeks a label update. The target condi…
-
FDA label_change · 2021-06-17FDA Approved: ZOLADEX — Supplemental Application (TerSera Therapeutics LLC)
FDA supplemental application for ZOLADEX (goserelin) submitted by TerSera Therapeutics LLC, likely related to labeling changes for the produ…
-
CLINICAL_TRIALS trial_result · 2021-06-11Clinical Trial Update: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3) [Phase 3]
A Phase 3 trial ASTEROID 3 evaluating vilaprisan in uterine fibroids was terminated with posted results.
-
CLINICAL_TRIALS trial_result · 2021-06-09Clinical Trial Update: Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids [Phase 3]
Phase 3 trial update on efficacy and safety of OBE2109 for heavy menstrual bleeding in uterine fibroids.
-
FDA approval · 2021-05-26FDA Approved: MYFEMBREE — Original Application (Sumitomo Pharma America, Inc)
FDA approved MYFEMBREE, a fixed-dose combination of relugolix, estradiol hemihydrate, and norethindrone acetate, for the treatment of heavy …
-
CLINICAL_TRIALS trial_result · 2021-04-30Clinical Trial Update: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4) [Phase 3]
Phase 3 trial assessing vilaprisan for uterine fibroids was terminated; results posted.
-
CLINICAL_TRIALS trial_result · 2021-03-05Clinical Trial Update: Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids [Phase 3]
Phase 3 trial update assessing efficacy and safety of OBE2109 in women with heavy menstrual bleeding due to uterine fibroids.
-
CLINICAL_TRIALS trial_result · 2021-02-04Clinical Trial Update: Laparoscopic Enclosed Morcellation; Electromechanic Morcellation vs Vaginal Removal [NA]
Clinical trial update comparing laparoscopic enclosed morcellation and electromechanic morcellation vs vaginal removal for myoma, with compl…
-
FDA approval · 2021-02-01FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Leuprolide acetate submitted by Sandoz Inc. This action approves changes under the generic d…
-
EMA safety_alert · 2020-11-13Ulipristal acetate for uterine fibroids: EMA recommends restricting use
EMA recommends restricting the use of ulipristal acetate for uterine fibroids due to safety concerns.
-
CLINICAL_TRIALS trial_result · 2020-10-28Clinical Trial Update: Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids [Phase 3]
Phase 3 trial summary of Tumor-shrinking Decoction (TSD) for symptomatic uterine fibroids (leiomyoma) completed.
-
CLINICAL_TRIALS trial_result · 2020-10-23Clinical Trial Update: Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study [Phase 4]
A Phase 4 randomized, placebo-controlled trial assessing rectal misoprostol to reduce intraoperative blood loss in women undergoing myomecto…
-
CLINICAL_TRIALS trial_result · 2020-10-14Clinical Trial Update: Ulipristal Acetate 10 mg and Asisted Reproduction [Phase 3]
Phase 3 clinical trial of Ulipristal Acetate 10 mg in assisted reproduction for intramural/uterine fibroids has been terminated.