Y-mAbs announces U.S. FDA acceptance of biologics license application for Danyelza (naxitamab) for the treatment of neuroblastoma for priority review

2 June 2020 - Y-mAbs Therapeutics today announced that the biologics license application for Danyelza (naxitamab) for the treatment of patients ...

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Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

2 June 2020 - Novartis today announced that it has received notice from the US FDA that the agency has extended ...

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Sumitovant Biopharma announces Myovant Sciences' submission of new drug application to the FDA for once daily relugolix combination tablet for the treatment of women with uterine fibroids

1 June 2020 - Sumitovant Biopharma announced today that Myovant Sciences has submitted a new drug application to the U.S. FDA ...

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AVEO Oncology announces FDA acceptance for filing of a new drug application for tivozanib as a treatment of relapsed or refractory renal cell carcinoma

1 June 2020 - Tivozanib assigned PDUFA target action date of 31 March 2021; FDA indicates that it does not currently ...

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FDA accepts Shionogi’s supplemental new drug application with priority review for Fetroja (cefiderocol) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia

1 June 2020 - Shionogi today announced the U.S. FDA has accepted the company’s supplemental new drug application for Fetroja ...

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AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis

1 June 2020 - Submissions supported by two Phase 3 studies in which Rinvoq demonstrated improved joint outcomes, physical function and ...

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CytoDyn files request with FDA for priority review of BLA for first approval

1 June 2020 - If granted, the FDA is expected to take action on the Company’s BLA within six months. ...

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Orphazyme initiates rolling submission of new drug application for arimoclomol with US FDA in Niemann-Pick disease type C

29 May 2020 - EMA marketing authorisation application submission expected in H2 2020. ...

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FDA accepts for review Fresenius Kabi’s first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim

27 May 2020 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s biologics license ...

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Protalix BioTherapeutics and Chiesi Global Rare Diseases announce submission of biologics license application to U.S. FDA for pegunigalsidase alfa for the treatment of Fabry disease

28 May 2020 - Protalix BioTherapeutics together with its development and commercialisation partner Chiesi Global Rare Diseases, today announced the submission ...

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Technegas – US FDA new drug application – next milestone in approval process successfully achieved

27 May 2020 - Cyclopharm is pleased to announce that the Company, through its wholly owned subsidiary Cyclomedica Australia, has been ...

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FDA grants priority review of Nucala for patients with hypereosinophilic syndrome

27 May 2020 - An approval would give Nucala a third indication in an eosinophil driven disease. ...

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Rockwell Medical files new drug submission with Health Canada for marketing approval of Triferic AVNU

26 May 2020 - Rockwell Medical today announced the filing of a new drug submission with Health Canada for Triferic AVNU ...

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Aurinia completes submission of new drug application to the U.S. FDA for voclosporin for the treatment of lupus nephritis

26 May 2020 - Application supported by extensive global clinical program including the pivotal Phase 3 AURORA study and the ...

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Kala Pharmaceuticals announces FDA acceptance of new drug application for Eysuvis for dry eye disease

26 May 2020 - FDA sets PDUFA goal date of 30 October 2020. ...

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