Lilly Announces Topline Results for Solanezumab from the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study

INDIANAPOLIS, Feb. 10, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the analysis performed by Washington University School of Medicine in the Dominantly Inherited Alzhei

Latest News Clinical News 1146
Read All

U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma

SANTA MONICA, Calif.--(BUSINESS WIRE)--Feb. 10, 2020 -- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Appli

Latest News Clinical News 900
Read All

Genentech Provides Topline Results From Investigator-Led Phase II/III Trial With Gantenerumab in Rare Inherited Form of Alzheimer’s Disease

South San Francisco, CA -- February 9, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did

Latest News Clinical News 1064
Read All

Zogenix Announces Positive Top-line Results from Global Pivotal Phase 3 Trial of Fintepla for the Treatment of Lennox-Gastaut Syndrome

EMERYVILLE, Calif., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today reported positive top-line results from its

Latest News Clinical News 931
Read All

FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer

Morris Plains, N.J., April 22, 2020 — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today anno

Latest News NDA News 1795
Read All

Genentech’s Risdiplam Showed Significant Improvement in Motor Function in People Aged 2-25 With Type 2 or 3 Spinal Muscular Atrophy

South San Francisco, CA -- February 6, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today presented 1-year data from the pivotal Part 2 of SUNFISH, a global placebo-con

Latest News Clinical News 968
Read All

Regeneron Announces Expanded Collaboration with HHS to Develop Antibody Treatments for New Coronavirus

TARRYTOWN, N.Y., Feb. 4, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develo

Latest News Clinical News 853
Read All

FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

BOTHELL, Wash.--(BUSINESS WIRE) April 17, 2020 -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted approval to Tukysa™ (tucatinib) tablets in co

Latest News NDA News 1364
Read All

FDA Approves Pemazyre (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma

WILMINGTON, Del.--(BUSINESS WIRE)--Apr. 17, 2020 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre (pemigatinib), a kinase inhibitor indica

Latest News NDA News 1213
Read All

CTI BioPharma Establishes Accelerated Approval Pathway for Pacritinib in Treating Myelofibrosis Patients With Severe Thrombocytopenia

SEATTLE, Feb. 3, 2020 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that following a meeting with the U.S. Food and Drug Administration ("FDA" or "the Agency")

Latest News Clinical News 885
Read All

FDA Approves Jelmyto (mitomycin gel) for Treatment of Low-Grade Upper Tract Urothelial Cancer

April 15, 2020 -- Today, the U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC). Urothelial cancer is a cance

Latest News NDA News 931
Read All

FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

13 April 2020 -- AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that the US Food and Drug Administration (FDA) has approv

Latest News NDA News 1128
Read All
News
- CLINIEXPERT -
Int'l Clinical Service Expert

We are the leader
Because of our professionism