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EMA validates the marketing authorization for lung cancer drug nivolumab
By PBR Staff Writer
The European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) for Bristol-Myers Squibb' nivolumab to treat non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
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
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
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
GSK resolves risk management violation issue at Montana facility in US
By PBR Staff Writer
British drug-maker GlaxoSmithKline (GSK) has resolved the issue of Clean Air Act violation, associated with its failure to submit a risk management plan at its facility in Hamilton, Montana, US.
Regulatory Affairs > News
FDA committee recommends approval of Natpara to treat hypoparathyroidism
NPS Pharmaceuticals, a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, has announced that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 8 to 5 that the available data support the approval of Natpara (rhPTH [1-84]) for the long-term treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, or PTH.
Regulatory Affairs > News
US FDA approves Baxter and Halozyme's Hyqvia to treat primary immunodeficiency
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Baxter and Halozyme Therapeutics' Hyqvia as a subcutaneous treatment for adult patients with primary immunodeficiency (PI).
Regulatory Affairs > News
1-15 of 2863 results