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  1. FDA grants orphan drug status to Shire’s UC treatment SHP647

    The US Food and Drug Administration (FDA) has granted orphan drug designation to Shire’s investigational mucosal addressin cell adhesion molecule-1…
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    1 Dec
  2. AstraZeneca’s regulatory submission accepted for Tagrisso

    The European Medicines Agency (EMA) has accepted AstraZeneca’s variation to the marketing authorisation application (MAAv) submission for Tagrisso (osimertinib) to…
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    30 Nov
  3. GSK seeks FDA approval for tafenoquine to treat P. vivax malaria

    GSK has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of…
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    30 Nov
  4. Sobi receives approval for Orfadin to treat HT-1 patients in Canada

    Swedish Orphan Biovitrum (Sobi) has received approval from Health Canada for an oral suspension formulation of Orfadin (nitisinone) to treat…
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    29 Nov
  5. US FDA grants fast-track status to Stealth’s elamipretide

    The US Food and Drug Administration (FDA) has granted fast-track designation for Stealth BioTherapeutics’ lead candidate, elamipretide, to treat patients…
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    29 Nov
  6. Biogen and Alkermes to develop ALKS 8700 for MS treatment

    Biogen has entered a global licence and collaboration agreement with Alkermes for the development and commercialisation of ALKS 8700 to…
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    29 Nov
  7. HitGen to identify new small molecule leads for Boehringer

    China-based biotechnology company HitGen has entered a drug discovery research collaboration with German firm Boehringer Ingelheim to discover new small…
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    28 Nov
  8. Pharming submits application to FDA for Ruconest to treat HAE

    Netherlands-based biotechnology company Pharming Group has submitted a supplemental biologics licence application (BLA) to the US Food and Drug Administration…
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    28 Nov
  9. Merck to submit CDF proposal for cancer drug

    The UK National Institute for Health and Care Excellence (NICE) has invited Merck to submit a Cancer Drugs Fund (CDF)…
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    28 Nov
  10. GSK and Innoviva file sNDA for expanded scope of Trelegy Ellipta

    GlaxoSmithKline (GSK) and Innoviva have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA)…
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    27 Nov
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