Relationships & Accomplishments

                  FDA Approves Mycovia Pharmaceuticals’ VIVJOA™ (oteseconazole), the First and Only FDA-Approved Medication for Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection)   - Approval of VIVJOA™ marks a significant therapeutic advancement for reducing… » Read More

Download as PDF Ibrexafungerp, the only fungicidal oral treatment for vaginal yeast infections, successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints. SCYNEXIS will submit a supplemental New Drug Application (sNDA) for BREXAFEMME® (ibrexafungerp… » Read More

FDA Accepts Arcutis Biotherapeutics’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis December 22, 2021 at 4:01 PM EST FDA has set a target action date of July 29, 2022 NDA supported by positive efficacy… » Read More

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S. Additional data show a booster increases protection 94 percent protection in the U.S. with booster given at two… » Read More

Myovant Sciences Announces European Commission Approval for RYEQO® for the Treatment of Women With Uterine Fibroids July 20, 2021 02:00 ET | Source: Myovant Sciences, Inc. RYEQO is the first and only once-daily long-term treatment for uterine fibroids in Europe Indication has… » Read More

Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response Demonstrated strong neutralizing antibody activity against the Delta (B.1.617.2) variant   Persistent immune responses through at least eight months NEW… » Read More

SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections June 02, 2021 07:30 ET | Source: Scynexis Approval of BREXAFEMME (ibrexafungerp) represents the first approved drug in a novel antifungal class in… » Read More

June 3, 2021 Dermavant Submits New Drug Application (NDA) to FDA for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis – NDA is supported by positive data from the Phase 3 PSOARING 1 and PSOARING 2 pivotal efficacy… » Read More

Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE®, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids May 26, 2021 at 4:15 PM EDT PDF Version In the Phase 3 LIBERTY 1 and LIBERTY 2 studies, MYFEMBREE demonstrated… » Read More

Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo May 17, 2021  DownloadPDF Format (opens in new window) -Primary and key secondary endpoints met in both TRuE-V1 and TRuE-V2 studies -Data will support… » Read More