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Regulatory Affairs

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
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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
Podcast – Industrial Design Considerations for Auto Injectors
The design, development and manufacturing of a successful auto injector project requires not only the seamless collaboration between the biopharmaceutical company and key partners, but also robust design and manufacturing capabilities that can ultimately reflect the desired device characteristics. With industrial design often the initial starting point of a project, possessing a strong in-house industrial team can mean more efficient communication with production teams which can lead to faster prototyping and design verification.
Regulatory Affairs > Press Releases
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
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