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1-15 of 2837 results
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
Bristol-Myers's hepatitis C infection combination therapy gets European approval
By PBR Staff Writer
Bristol-Myers Squibb (BMS) has received approval from the European Commission for Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), to treat patients with chronic hepatitis C infection (HCV).
Regulatory Affairs > News
FDA approves GlaxoSmithKline's anaemia drug Promacta
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) supplemental new drug application (sNDA) for Promacta (eltrombopag) to treat patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
Regulatory Affairs > News
EMA agrees to review Basilea’s isavuconazole marketing authorization application
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted to review Basilea Pharmaceutica’s isavuconazole marketing authorization application (MAA) for the treatment of invasive aspergillosis and mucormycosis (zygomycosis) in adults.
Regulatory Affairs > News
US DEA tightens restrictions on painkiller prescriptions
By PBR Staff Writer
The US Department of Drug Enforcement Administration (DEA) is all set to roll out new restrictions on several products blended with hydrocodone, which has turned out to be a highly prescribed and addictive painkiller in America.
Regulatory Affairs > News
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
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
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
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
1-15 of 2837 results