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1-15 of 2851 results
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
FDA approves Takeda and Orexigen's Contrave for chronic weight management
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals USA and Orexigen Therapeutics’ Contrave (naltrexone HCI and bupropion HCI) extended-release tablets for chronic weight management.
Regulatory Affairs > News
FDA grants orphan drug status for Viamet's VT-1129 to treat cryptococcal meningitis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Viamet Pharmaceuticals' VT-1129, a potent and selective, oral, antifungal agent, to treat cryptococcal meningitis, a life-threatening invasive fungal infection of the lining of the brain and spinal cord.
Regulatory Affairs > News
Lilly and Boehringer's insulin glargine product gets European marketing approval
By PBR Staff Writer
Eli Lilly and Company and Boehringer Ingelheim have received marketing authorization from the European Commission (EC) for their insulin glargine product to treat diabetes in adults, adolescents and children aged two years and above.
Regulatory Affairs > News
Roche's RoACTEMRA gets European approval to treat early rheumatoid arthritis
By PBR Staff Writer
The European Commission has approved Roche's RoACTEMRA (tocilizumab) for use in patients with severe, active and progressive rheumatoid arthritis (RA) who previously have not been treated with methotrexate (MTX).
Regulatory Affairs > News
FDA approves ferric citrate for CKD dialysis patients with hyperphosphatemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Keryx Biopharmaceuticals for ferric citrate (formerly Zerenex) to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
Regulatory Affairs > News
FDA approves Merck's anti-PD-1 therapy Keytruda
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Merck's Keytruda (pembrolizumab) to treat patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Regulatory Affairs > News
Bayer seeks marketing approval for aflibercept solution for injection in Japan
By PBR Staff Writer
Bayer Yakuhin has submitted marketing authorization application (MAA) in Japan for aflibercept solution for injection into the eye in patients with macular edema secondary to branch retinal vein occlusion (BRVO).
Regulatory Affairs > News
Halozyme gets fast track status for PEGPH20 program in metastatic pancreatic cancer
By PBR Staff Writer
Halozyme Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its program investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel to treat patients with metastatic pancreatic cancer.
Regulatory Affairs > News
ViiV Healthcare's HIV drug Triumeq gets marketing authorisation in Europe
By PBR Staff Writer
The European Commission (EC) has granted marketing authorization for UK-based ViiV Healthcare's Triumeq tablets to treat HIV in adults and adolescents aged 12 years and older and weighing at least 40kg.
Regulatory Affairs > News
FDA grants orphan drug status for Arena's hypertension drug candidate APD811
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug status for Arena Pharmaceuticals' APD811, an orally available agonist of the prostacyclin (IP) receptor to treat pulmonary arterial hypertension (PAH).
Regulatory Affairs > News
VentiRx gets FDA fast track status for motolimod to treat ovarian cancer
By PBR Staff Writer
VentiRx Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for the investigation of motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) to treat women with ovarian cancer.
Regulatory Affairs > News
FDA approves Pfizer and Protalix's Elelyso to treat type 1 Gaucher Disease
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Pfizer and Protalix BioTherapeutics' Elelyso (taliglucerase alfa) for injection to treat adult and pediatric patients with confirmed diagnosis of Type 1 Gaucher disease.
Regulatory Affairs > News
1-15 of 2851 results