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1-15 of 3074 results
Adaptimmune gets FDA acceptance for IND application for MAGE-A10 T in NSCLC patients
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted UK-based biopharmaceutical firm Adaptimmune Therapeutics' investigational new drug (IND) application for autologous genetically modified T-cells expressing enhanced T cell receptors (TCRs) specific for its therapeutic candidate MAGE A10 (MAGE-A10 T) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA approves Spriaso's NDA for codeine antitussive with anti-histamine
By PBR Staff Writer
The US food and Drug Administration (FDA) has granted approval for Spriaso's new drug application (NDA) for Tuxarin ER, a high strength long acting Rx cough/cold combination product containing codeine and chlorpheniramine.
Regulatory Affairs > News
Gilead submits NDA to FDA for single tablet regimen R/F/TAF to treat HIV
By PBR Staff Writer
Gilead Sciences has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for an investigational, once-daily single tablet combination regimen to treat HIV-1 infection in adult and pediatric patients 12 years of age and older.
Regulatory Affairs > News
Santen files IND application with FDA for DE-122 to treat wet AMD
By PBR Staff Writer
Santen Pharmaceutical has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) seeking approval to begin clinical studies for DE-122 to treat wet age-related macular degeneration (wet AMD).
Regulatory Affairs > News
Theravance gets marketing authorization for Vibativ in Russia to treat gram-positive bacterial infections
By PBR Staff Writer
Theravance Biopharma has received marketing authorization from the Ministry of Health of the Russian Federation for Vibativ (telavancin) to treat complicated skin and soft tissue infections, as well as nosocomial pneumonia, caused by Gram-positive bacteria, including methicillin-resistance Staphylococcus aureus (MRSA).
Regulatory Affairs > News
Aridis gets FDA fast track status for pneumonia drug Aerucin
By PBR Staff Writer
US-based Aridis Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for its fully human monoclonal antibody Aerucin to treat hospital-acquired and ventilator-associated pneumonia caused by pseudomonas aeruginosa.
Regulatory Affairs > News
BioBlast gets orphan drug status for cabaletta in Europe to teat spinocerebellar ataxia
BioBlast Pharma (ORPN), a clinical-stage orphan disease-focused biotechnology company, announced that it has been granted Orphan Drug Designation by the European Commission for Cabaletta for the treatment of Spinocerebellar Ataxia (SCA).
Regulatory Affairs > News
CDC Advisory Committee votes to recommend Pfizer's serogroup B meningococcal disease vaccination
By PBR Staff Writer
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend Pfizer's serogroup B meningococcal disease vaccination including Trumenba (meningococcal group B vaccine) for adolescents and young adults 16 through 23 years of age.
Regulatory Affairs > News
AveXis' gene therapy treatment for spinal muscular atrophy gets EMA orphan drug status
By PBR Staff Writer
US-based gene therapy company AveXis has secured orphan drug designation from the European Medicines Agency (EMA) for its gene transfer therapeutic currently in clinical development in the US to treat type 1 Spinal Muscular Atrophy (SMA), an autosomal-recessive genetic disorder.
Regulatory Affairs > News
FDA approves Eisai's Fycompa to treat primary generalized tonic-clonic seizures
Eisai announced that its US subsidiary Eisai Inc. has received approval from the US Food and Drug Administration (FDA) for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa (perampanel hydrate) as an adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.
Regulatory Affairs > News
FDA grants fast track status for Forum's encenicline to treat cognitive impairment in schizophrenia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation to Forum Pharmaceuticals' lead compound encenicline, which is being developed to treat cognitive impairment in schizophrenia.
Regulatory Affairs > News
XOMA gets FDA orphan status for XOMA 358 to treat congenital hyperinsulinism
XOMA Corporation (XOMA), a leader in the discovery and development of therapeutic antibodies, announced XOMA 358, a fully human allosteric monoclonal antibody that reduces both the binding of insulin to its receptor and downstream insulin signaling, has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of congenital hyperinsulinism (HI).
Regulatory Affairs > News
Genticel gets FDA nod to begin US Phase I trial of HPV therapeutic vaccine candidate GTL001
By PBR Staff Writer
French biotechnology firm Genticel has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to conduct a US Phase I trial of GTL001 in patients infected with human papillomavirus (HPV) 16 and/or 18.
Regulatory Affairs > News
FDA grants orphan status for Protalex's PRTX-100 to treat immune thrombocytopenia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for Protalex's lead product, PRTX-100, for the treatment of immune thrombocytopenia (ITP), an autoimmune-mediated condition.
Regulatory Affairs > News
Sucampo's IND for pivotal study of constipation drug Amitiza gets China FDA acceptance
By PBR Staff Writer
US-based Sucampo Pharmaceuticals has received accepted for its investigational new drug (IND) application from the China Food and Drug Administration (CFDA) for a pivotal study of Amitiza (lubiprostone) in patients with chronic idiopathic constipation.
Regulatory Affairs > News
1-15 of 3074 results