Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs

Regulatory Affairs

Bristol-Myers Squibb announces multiple regulatory milestones for Opdivo in US and EU Bristol-Myers Squibb Company announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, in the U.S. and European Union.
Regulatory Affairs > News
Rexahn's RX-3117 gets FDA orphan drug status for pancreatic cancer treatment By PBR Staff Writer
US-based Rexahn Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for its RX-3117, a new small molecule anti-metabolite, to treat patients with pancreatic cancer.
Regulatory Affairs > News Gilead files NDA for fixed-dose combination of edipasvir/Sofosbuvir in Japan By PBR Staff Writer
Gilead Sciences has submitted a new drug application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) seeking approval for an investigational once-daily fixed-dose combination (FDC) of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400mg to treat chronic genotype 1 hepatitis C virus (HCV) infection in adults.
Regulatory Affairs > News
See more Regulatory Affairs news

Latest Regulatory Affairs News and Insight

View all Regulatory Affairs news or find news targeted to your interests
NOXXON gets FDA orphan drug status for olaptesed pegol to treat glioblastoma
By PBR Staff Writer
NOXXON Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for one of its Spiegelmer therapeutics, olaptesed pegol (NOX-A12), indicated to treat glioblastoma in conjunction with radiotherapy.
Regulatory Affairs > News
FDA approves Galmed's request for fast track status of aramchol
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Israel-based Galmed Pharmaceuticals' request for fast track designation of its product candidate, aramchol, indicated to treat Non-Alcoholic Steato-Hepatitis (NASH), a chronic disease.
Regulatory Affairs > News
FDA grants fast track status to MedImmune's MEDI3902 for prevention of P. aeruginosa
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation to MedImmune's investigational monoclonal antibody (mAb) MEDI3902 to prevent nosocomial pneumonia caused by Pseudomonas aeruginosa (P. aeruginosa).
Regulatory Affairs > News
Celgene's Otezla psoriasis drug obtains FDA approval
By PBR Staff Writer
US-based biotechnology firm Celgene has received approval from the US Food and Drug Administration (FDA) for its oral, selective inhibitor of phosphodiesterase 4 (PDE4) Otezla (apremilast) to treat patients with moderate to severe plaque psoriasis.
Regulatory Affairs > News
Amgen files BLA for investigational BiTE immunotherapy blinatumomab to treat leukemia
By PBR Staff Writer
Amgen has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab.
Regulatory Affairs > News
Japan approves Bayer's Eylea to treat myopic choroidal neovascularization
By PBR Staff Writer
Japan' Ministry of Health, Labour and Welfare (MHLW) has approved Bayer HealthCare's Eylea (aflibercept solution for injection) to treat myopic choroidal neovascularization (myopic CNV).
Regulatory Affairs > News
Lilly's Trulicity type 2 diabetes drug gets FDA approval
By PBR Staff Writer
Eli Lilly and Company has received approval from the US Food and Drug Administration for Trulicity (dulaglutide) as a treatment option for adults with type 2 diabetes.
Regulatory Affairs > News
3R PHARMA CONSULTING - Reducing Regulatory Risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world.
Regulatory Affairs > Suppliers
Manuel Zahn to Attend GMP-BERATER Tage 2014
Manuel Zahn, founder and managing director of 3R Pharma Consulting will attend the GMP-BERATER Tage 2014. The meeting will see a small group of GMP experts meet and discuss new GMP regulations and will share their experiences at Schloss Reinach, near Freiburg, Germany, 8-9 October 2014.
Regulatory Affairs > Press Releases
Soligenix secured FDA clearance of Phase III trial of lymphoma drug SGX301
By PBR Staff Writer
US-based biopharmaceutical firm Soligenix has entered into an agreement with the US Food and Drug Administration (FDA) on the design of a major Phase III clinical trial assessing its product SGX301 (synthetic hypericin) to treat cutaneous T-cell lymphoma (CTCL).
Regulatory Affairs > News
View all Regulatory Affairs news or find news targeted to your interests

Buy the latest industry research online today!
Shire Plc : Pharmaceuticals & Healthcare - Company Profile, SWOT & Financial Report 03 October 2013 This report is a crucial resource for industry executives and anyone looking to access key information about "Shire Plc" The report utilizes a wide range of primary and secondary sources, which are analyzed and presented in a consistent and easily accessible format. ICD Research strictly follows a standardized research methodology to ensure high levels of data quality and these characteristics guarantee a unique report. Buy online from $250