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214 articles with TherapeuticsMD, Inc.
BIJUVA is the only FDA-approved Therapy Combining Bio-identical Estradiol and Progesterone for Moderate to Severe Vasomotor Symptoms due to Menopause in a Single Capsule
TherapeuticsMD Announces Oral and Poster Presentations on BIJUVA™ and ANNOVERA™ at the Endocrine Society 2019 Annual Meeting
Four Posters Will Present BIJUVA Phase 3 REPLENISH Data About Improvements in Hot Flushes, Night Sweats, Sweating, Quality of Sleep, and Incidence of Vaginal Bleeding in Postmenopausal Women
TherapeuticsMD Announces Oral Presentations on BIJUVA and ANNOVERA, and Poster Presentations Related to Menopause Symptoms and Treatments at 2019 ISSWSH/ISSM Joint Meeting
TherapeuticsMD, Inc. announced the schedule of oral presentations on clinical data for BIJUVATM and ANNOVERATM, and poster presentations related to menopause symptoms and treatments, at the International Society for the Study of Women’s Sexual Health and the International Society of Sexual Medicine joint annual meeting in Atlanta, GA on March 8-9, 2019.
TherapeuticsMD, Inc., an innovative, leading women’s healthcare company, announced its commercial and corporate update for the fourth quarter and full-year ended December 31, 2018.
Executive Management to Host Conference Call on February 21, 2019 at 4:30 p.m. ET
TherapeuticsMD, Inc. today announced that the company will participate in three upcoming healthcare investor conferences. Chief Executive Officer Robert G. Finizio will provide an overview of the company at the conferences.
-Strong early launch indicators for IMVEXXY™-
-Executive Management to Host Conference Call on November 7, 2018 at 4:30 p.m. ET-
TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA™ (Estradiol and Progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
BIJUVA is the First and Only FDA-Approved Hormone Therapy of Bio-Identical Estradiol in Combination with Bio-Identical Progesterone
This week will have moderate activity by the U.S. Food and Drug Administration (FDA). Although they jumped the gun on Regeneron and Sanofi’s cancer drug, there are still plenty of other decisions being made this week. Here’s a look.
TherapeuticsMD Announces Multiple Presentations Related to Imvexxy™ and TX-001HR at the 2018 Annual Meeting of the North American Menopause Society
TherapeuticsMD, Inc. today announced the schedule of ten oral presentations and posters at NAMS 2018, the annual meeting of the North American Menopause Society being held in San Diego, California on October 3-6, 2018
TherapeuticsMD, Inc. today announced that the Company has entered into discussions with the U.S. Food and Drug Administration (FDA) regarding the proposed label for TX-001HR, the Company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.
Chief Executive Officer Robert G. Finizio will participate in the conference.
TherapeuticsMD Announces the FDA has Granted AnnoveraTM Marketing Exclusivity as a New Chemical Entity
TherapeuticsMD, Inc. has been granted marketing exclusivity as a new chemical entity (NCE) from the U.S. Food and Drug Administration.
Imvexxy 4 mcg dose now commercially available in the United States
A patient advocacy organization is putting its weight behind an effort to urge the U.S. Food and Drug Administration to reconsider its recent decision to reject a treatment for the rare lipid disorder familial chylomicronemia syndrome (FCS). That rejection lead to a round of layoffs at Akcea.
8/31/2018The U.S. Food and Drug Administration has had a busy August. In addition to the number of draft guidance documents the agency issued during the month, the FDA has also been busy approving a number of new treatments for a variety of diseases.
TherapeuticsMD, Inc. announced that the company will present at the 13th Annual Wells Fargo Securities Healthcare Conference being held on September 5-6, 2018 in Boston. Robert G. Finizio, Chief Executive Officer, and Brian Bernick, M.D., Co-founder, will participate in the conference.
The U.S. Food and Drug Administration has done another about-face. Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA has now approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
This week had three important target action dates, known as Prescription Drug User Fee Act (PDUFA) dates, for the U.S. Food and Drug Administration (FDA). The agency got ahead of its schedule and approved all of these drugs ahead of schedule. Let’s take a look.