Specialty Pharma Journal Specialty, Precision & Technology
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen. As part of the Breakthrough Therapy …
Tag Archives: Breakthrough Therapy
June, 2016
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24 June
FDA Grants Breakthrough Therapy Designation to Incyte’s Jakafi for GVHD
WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD. Breakthrough Therapy Designation is designed …
May, 2016
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2 May
FDA Approves Acadia’s Nuplazid for Parkinson’s-Related Psychosis
The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. Hallucinations or delusions can occur in as many as 50 percent of patients with Parkinson’s disease at some time during …
April, 2016
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25 April
Bristol-Myers Squibb’s Opdivo Receives Breakthrough Therapy Designation
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. The Breakthrough Therapy Designation is …
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20 April
FDA Grants Merck’s Keytruda Breakthrough Therapy in Classical Hodgkin Lymphoma
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This is …
March, 2016
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30 March
FDA Panel Votes in Favor of Acadia Pharmaceuticals’ Drug for Parkinson’s Disease Psychosis
SAN DIEGO–(BUSINESS WIRE)–Mar. 29, 2016– ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 …
February, 2016
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22 February
Trevena’s Pain Drug Receives FDA Breakthrough Therapy Designation
Trevena, Inc. (NASDAQ: TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the Company’s lead product candidate, intravenous oliceridine (TRV130), for the management …
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8 February
Immunomedics’ TNBC Drug Receives Breakthrough Therapy Designation from the FDA
Morris Plains, NJ, February 5, 2016 — Immunomedics, Inc., (Nasdaq: IMMU) today announced that its lead investigational antibody-drug conjugate, sacituzumab govitecan, or IMMU-132, has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer (TNBC) who have failed at least 2 prior therapies for …
January, 2016
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20 January
FDA Grants Breakthrough Therapy Designation to AbbVie’s Chronic Lymphocytic Leukemia Drug
NORTH CHICAGO, Ill., Jan. 20, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Venetoclax is an inhibitor …
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19 January
Eisai’s Kidney Cancer Drug Receives Priority Review from the FDA
WOODCLIFF LAKE, N.J., Jan. 17, 2016 /PRNewswire/ — Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for lenvatinib for the potential treatment of patients with unresectable advanced or metastatic renal cell carcinoma (RCC) in combination with …