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119 Current news about the topic orphan drug designation

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Merck Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy

12-Dec-2018

Merck announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to M7824, the first regulatory designation for the bifunctional immunotherapy, for the treatment of biliary tract cancer (BTC). The FDA orphan drug designation follows the recent presentation ...

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Bioverativ to acquire biotechnology company True North Therapeutics

26-May-2017

Bioverativ Inc., a biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders, announced that it has entered into a definitive agreement to acquire South San Francisco-based True North Therapeutics, a ...

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Merck and Pfizer Receive Positive Opinion from EMA Committee

26-Nov-2015

Merck and Pfizer announced that the European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for Orphan Drug designation (ODD) for avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, pending an official decision by ...

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Hybrigenics’ inecalcitol gets Orphan Drug designation for the treatment of Acute Myeloid Leukemia in the United States

18-Aug-2015

Hybrigenics announcesthe Orphan Drug designation by the American Food and Drug Administration of inecalcitol for the treatment of acute myeloid leukemia (AML) in the United States. This favourable decision is based onin vitroandin vivopreclinical evidence showing the synergy between ...

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Rett syndrome: Newron Receives FDA Orphan Drug Designation for Sarizotan

15-Jul-2015

Newron Pharmaceuticals S.p.A. announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Newron’s New Chemical Entity (NCE) sarizotan for treatment of Rett syndrome. Newron also recently announced that it received a positive opinion from the Committee for ...

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FDA Awards Isarna Orphan Drug Designation for ISTH0036 to Improve Glaucoma Treatment Outcome

12-Jun-2015

Isarna Therapeutics announced that the Food and Drug Administration (FDA) has granted orphan drug designation for ISTH0036, a locked nucleic acid-modified antisense oligonucleotide, for the prevention of scarring post glaucoma filtration surgery. The FDA decision follows recently announced EMA ...

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FDA Grants Orphan Status for ATX-F8-117 for the treatment of Haemophilia A patients in the US

11-Jun-2015

Apitope announced that pre-clinical product candidate ATX-F8-117 has been granted Orphan Drug Status by the US Food and Drug Administration (FDA) for the prevention or treatment of inhibitors in haemophilia A patients with inhibitors or at the risk of producing inhibitors. Commenting on the ...

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First medicine for rare blood cancer

EMA recommends Imbruvica for the treatment of Waldenstrӧm’s macroglobulinaemia

27-May-2015

The European Medicines Agency (EMA) has recommended extending the use of Imbruvica (ibrutinib) to include the treatment of patients with Waldenstrӧm’s macroglobulinaemia, a rare blood cell cancer. Imbruvica is the first medicine that is recommended for this disease.The medicine is indicated for ...

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Isarna Announces Orphan Drug Designation in the European Union for ISTH0036 to Treat Advanced-Stage Glaucoma

26-May-2015

Isarna Therapeutics announced that the European Medicines Agency (EMA) has granted orphan drug designation for ISTH0036, a locked nucleic acid-modified antisense oligonucleotide, for the prevention of scarring post filtration surgery in glaucoma. With EMA Orphan Drug Designation, Isarna is ...

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Sobi receives orphan drug designation for Elocta in Switzerland

17-Apr-2015

Swedish Orphan Biovitrum AB has received orphan drug designation in Switzerland for its long acting haemophilia drug candidate Elocta (rFVIIIFc) developed for the treatment of haemophilia A. An orphan drug designation is to encourage the development of medicines for rare diseases and provides ...

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