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Boehringer Ingelheim receives positive CHMP opinion for adalimumab biosimilar Cyltezo
Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.
Regulatory Affairs > News
FDA approves biosimilar of Avastin to treat five types of cancer
By PBR Staff Writer
Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Mvasi (bevacizumab-awwb), a biosimilar to Roche's Avastin, to treat five types of cancer.
Regulatory Affairs > News
Regeneron, Sanofi get FDA breakthrough therapy status for skin cancer drug cemiplimab
By PBR Staff Writer
Regeneron Pharmaceuticals and Sanofi have secured breakthrough therapy status from the US Food and Drug Administration (FDA) for cemiplimab (REGN2810) to treat advanced cutaneous squamous cell carcinoma (CSCC).
Regulatory Affairs > News
Novo Nordisk settles US suit over diabetes drug Victoza
By PBR Staff Writer
Novo Nordisk has agreed to pay $58.65m to settle charges relating to the marketing of its type 2 diabetes drug Victoza (liraglutide) in the US.
Regulatory Affairs > News
Deciphera gets FDA orphan drug designation for DCC-2618 to treat glioblastoma multiforme and anaplastic astrocytoma
Deciphera Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, for the treatment of glioblastoma multiforme and anaplastic astrocytoma.
Regulatory Affairs > News
EC approves Merck’s Keytruda to treat urothelial carcinoma
By PBR Staff Writer
Merck has secured approval from the European Commission (EC) for its Keytruda (pembrolizumab) to treat certain patients with locally advanced or metastatic urothelial carcinoma (a type of bladder cancer).
Regulatory Affairs > News
Oragenics doses first patient in phase 2 clinical trial of AG013 for oral mucositis
Oragenics has announced that the first patient has been dosed in its Phase 2 clinical trial of AG013 for the treatment of oral mucositis (OM).
Regulatory Affairs > News
Sunovion seeks FDA approval for dasotraline to treat patients with ADHD
Sunovion Pharmaceuticals announced that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for dasotraline, a novel investigational, dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of children, adolescents and adults with attention deficit hyperactivity disorder (ADHD).
Regulatory Affairs > News
Pfizer gets FDA nod for acute myeloid leukaemia drug Mylotarg
By PBR Staff Writer
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Mylotarg (gemtuzumab ozogamicin) to treat adults with newly diagnosed CD33-positive acute myeloid leukemia (AML).
Regulatory Affairs > News
Bayer submits BLA to FDA for BAY94-9027 to treat Hemophilia A
By PBR Staff Writer
Bayer is seeking approval from the US Food and Drug Administration (FDA) for its its long-acting factor VIII, BAY94-9027, to treat Hemophilia A.
Regulatory Affairs > News
Novartis gets FDA nod for cancer treatment Kymriah
By PBR Staff Writer
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel or CTL019) to treat children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
European Commission grants approval for Mavenclad
Merck announced that the European Commission (EC) has granted marketing authorization for Mavenclad 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis*(RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.
Regulatory Affairs > News
Samsung Bioepis’ Humira biosimilar Imraldi approved in Europe
By EBR Staff Writer
Samsung Bioepis' Imraldi, the anti-TNF biosimilar of Humira (adalimumab), has been approved by the European Commission (EC) for all indications of the AbbVie monoclonal antibody.
Regulatory Affairs > News
European Commission approves Novartis breast cancer drug Kisqali
Novartis’ breast cancer drug Kisqal has secured authorisation from the European Commission for the treatment of advanced breast cancer.
Regulatory Affairs > News
Epygenix gets FDA orphan drug status for EPX-300 to treat Dravet Syndrome
Epygenix Therapeutics has secured orphan drug status from the US Food and Drug Administration (FDA) for its EPX-300 to treat patients with Dravet Syndrome.
Regulatory Affairs > News
136-150 of 3654 results