Relationships & Accomplishments

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

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

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

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

Phathom Pharmaceuticals Announces Positive Topline Results from Pivotal Phase 3 Trial of Vonoprazan in Helicobacter pylori (H. pylori) Infection; Study Met All Primary and Secondary Endpoints April 29, 2021 at 4:01 PM EDT PDF Version Both vonoprazan-based treatment regimens demonstrated… » Read More

Otezla Treatment Resulted in Significant Improvements in Measures of Mild-to-Moderate Psoriasis Compared With Placebo Data Will be Submitted to the U.S. Food and Drug Administration (FDA) for Inclusion in Otezla Prescribing Information THOUSAND OAKS, Calif., May 6, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive… » Read More