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

EISAI seeks approval to expand antiepilepsy agent Fycompa as adjunctive cure of primary generalised tonic-clonic seizures By PBR Staff Writer
Eisai announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for the indication expansion of its in-house developed antiepileptic drug Fycompa as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC).
Regulatory Affairs > News
FDA authorizes Kronus ZnT8Ab Elisa Assay for marketing By PBR Staff Writer
The US Food and Drug Administration (FDA) has authorized the marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that helps in determination of Type 1 Diabetes.
Regulatory Affairs > News US DoJ clears AstraZeneca’s clinical trial By PBR Staff Writer
The United States Department of Justice (US DoJ) has concluded its probe into PLATO clinical trial for AstraZeneca's Brilinta (ticagrelor), with no further action required.
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
FDA approves Cerdelga for Type 1 Gaucher disease treatment
By PBR Staff Writer
Genzyme-built drug Cerdelga has been approved by the US Food and Drug Administration (FDA) to treat adult patients with the Type 1 form of Gaucher disease.
Regulatory Affairs > News
Pfizer submits NDA for breast cancer treatment Palbociclib to FDA
By PBR Staff Writer
Pfizer has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for palbociclib to treat postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.
Regulatory Affairs > News
FDA grants fast track status for Agios' AG-221 to treat acute myelogenous leukemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted Fast Track designation to Agios Pharmaceuticals' AG-221, a first-in-class, oral, selective, potent IDH2 mutant inhibitor, to treat patients with acute myelogenous leukemia (AML) that harbor an isocitrate dehydrogenase-2 (IDH2) mutation.
Regulatory Affairs > News
Biogen's multiple sclerosis drug Plegridy gets FDA approval
By PBR Staff Writer
US-based biotechnology firm Biogen Idec has received approval from the US Food and Drug Administration (FDA) for its Plegridy (peginterferon beta-1a) for the treatment of people with relapsing forms of multiple sclerosis (RMS).
Regulatory Affairs > News
Supernus receives FDA fast track designation for SPN-810
Supernus Pharmaceuticals, a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, has announced that the US Food and Drug Administration (FDA) has granted fast track designation for SPN-810 for the treatment of impulsive aggression in attention deficit hyperactivity disorder (ADHD).
Regulatory Affairs > News
INFOTEHNA Group - Pharmaceutical Software Solutions
INFOTEHNA Group is a leading provider of software solutions for the life sciences industries. We develop and deliver integral enterprise content, process management and regulatory compliance.
Regulatory Affairs > Suppliers
OncoSynergy's OS2966 glioblastoma treatment gets FDA orphan drug status
By PBR Staff Writer
The FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation for US-based biopharmaceutical firm OncoSynergy's investigational drug candidate OS2966, a neutralizing anti-CD29 monoclonal antibody to treat glioblastoma.
Regulatory Affairs > News
SHL to Exhibit at the 2014 PDA Conference in California, USA
The growth of the auto injector industry has been driven largely in part by the need to improve patient compliance and quality of life (QOL). From human factors and usability studies to new injection technologies and breakthrough manufacturing processes, the ultimate goal of an auto injector device is to enhance the injection experience while ensuring the desired drug is delivered safely and effectively.
Regulatory Affairs > Press Releases
FDA approves VELCADE retreatment in patients with multiple myeloma
Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, has announced that the U.S. Food and Drug Administration (FDA) has approved VELCADE (bortezomib) for the retreatment of adult patients with multiple myeloma (MM) who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment.
Regulatory Affairs > News
US allows use of experimental Zmapp Ebola drug in Liberia
By PBR Staff Writer
The White House and the US Food and Drug Administration have given their approval to send and allow the use of an experimental Ebola drug, Zmapp, in Liberia.
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