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RSS FeedPosted by Michael Wonder on 02 Jun 2020
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 ...
Posted by Michael Wonder on 02 Jun 2020
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 ...
Posted by Michael Wonder on 02 Jun 2020
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 ...
Posted by Michael Wonder on 02 Jun 2020
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 ...
Posted by Michael Wonder on 02 Jun 2020
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 ...
Posted by Michael Wonder on 01 Jun 2020
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 ...
Posted by Michael Wonder on 01 Jun 2020
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. ...
Posted by Michael Wonder on 01 Jun 2020
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. ...
Posted by Michael Wonder on 29 May 2020
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 ...
Posted by Michael Wonder on 28 May 2020
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 ...
Posted by Michael Wonder on 28 May 2020
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 ...
Posted by Michael Wonder on 27 May 2020
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. ...
Posted by Michael Wonder on 26 May 2020
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 ...
Posted by Michael Wonder on 26 May 2020
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. ...
Posted by Michael Wonder on 24 May 2020
Zealand Pharma announces FDA acceptance of new drug application for the dasiglucagon HypoPal rescue pen for treatment of severe hypoglycemia
22 May 2020 - PDUFA target action date scheduled for 27 March 2021. ...