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1-15 of 2990 results
EMA committee issues positive opinion for Novartis' lung cancer drug Zykadia
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion recommending approval for Novartis' Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
Regulatory Affairs > News
FDA approves Actavis' antibacterial drug Avycaz to treat cIAI and cUTI
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Actavis' antibacterial drug Avycaz (ceftazidime-avibactam) to treat adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI).
Regulatory Affairs > News
FDA accepts for review Teva's NDA for pain management tablets
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review the new drug application (NDA) for Teva Pharmaceutical's hydrocodone bitartrate extended-release (ER) tablets formulated with its abuse deterrence technology (CEP-33237) for pain management.
Regulatory Affairs > News
FDA approves Novartis's multiple myeloma drug Farydak
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Swiss drugmaker Novartis's Farydak (panobinostat) to treat patients with multiple myeloma.
Regulatory Affairs > News
Seattle submits supplemental BLA to FDA for Phase III Aethera trial of Adcetris in HL patients
Seattle Genetics has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) based on data from Phase III Aethera trial of Adcetris (Brentuximab Vedotin) in post-transplant hodgkin lymphoma (HL) patients at high risk of relapse.
Regulatory Affairs > News
aTyr Pharma's Resolaris gets EMA orphan drug status for FSHD
By PBR Staff Writer
The European Commission (EC) has granted orphan drug designation for US-based biotherapeutics firm aTyr Pharma's investigational new drug Resolaris to treat facioscapulohumeral muscular dystrophy (FSHD).
Regulatory Affairs > News
FDA approves Celgene's Revlimid in combination with dexamethasone to treat multiple myeloma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has expanded the existing indication for Celgene's Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (NDMM).
Regulatory Affairs > News
FDA approves Eisai's thyroid cancer drug Lenvima
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Eisai's receptor tyrosine kinase inhibitor Lenvima (lenvatinib) to treat locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).
Regulatory Affairs > News
Novartis gets FDA priority review for heart failure medicine LCZ696
By PBR Staff Writer
Swiss drug-maker Novartis has secured priority review designation from the US Food and Drug Administration (FDA) for its investigational medicine LCZ696, to treat heart failure with reduced ejection fraction (HFrEF).
Regulatory Affairs > News
Abbvie seeks approval in Japan for new treatment of patients with chronic HCV infection
By PBR Staff Writer
AbbVie has submitted a new drug application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for its investigational, all-oral ribavirin (RBV) and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment for patients with chronic hepatitis C virus (HCV) infection.
Regulatory Affairs > News
FDA grants orphan drug status for Targazyme's TZ101 for use with regulatory T cells
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Targazyme's fucosyltransferase enzymes and small molecule product, TZ101, to prevent and reduce the severity and incidence of graft versus host disease (GVHD) in patients eligible for hematologic stem cell transplant.
Regulatory Affairs > News
FDA grants orphan drug status for AIT's high dose nitric oxide formulation to treat CF
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for Advanced Inhalation Therapies' (AIT's) high dose formulation of nitric oxide (NO) and delivery system, AIT-CF, as adjunctive treatment of cystic fibrosis (CF).
Regulatory Affairs > News
FDA accepts for filing Inspirion Delivery's MorphaBond ER NDA
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for filing the new drug application (NDA) for Inspirion Delivery Technologies' (IDT) investigational drug, MorphaBond ER, an extended-release (ER), abuse-deterrent formulation of morphine for the management of pain.
Regulatory Affairs > News
FDA advisory committee to review Theravance's BREO ELLIPTA (FF/VI) for asthma
Theravance, announced that on March 19, 2015, the US Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss the supplemental New Drug Application (NDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREO ELLIPTA), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older.
Regulatory Affairs > News
GSK seeks EMA approval for additional indication of eltrombopag to treat ITP
By PBR Staff Writer
GlaxoSmithKline (GSK) has submitted a variation to the Marketing Authorization to the European Medicines Agency (EMA) seeking an additional indication for eltrombopag (Revolade) to treat paediatric patients aged one year and above with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Regulatory Affairs > News
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