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RSS FeedPosted by Michael Wonder on 09 Jul 2020
ChemoCentryx submits new drug application to the U.S. FDA for avacopan in ANCA associated vasculitis
9 July 2020 - ChemoCentryx today confirmed that the Company has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 09 Jul 2020
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for second-line treatment of patients with relapsed or refractory classical Hodgkin lymphoma
9 July 2020 - Application based on data comparing Keytruda to standard care (brentuximab vedotin) from pivotal Phase 3 KEYNOTE-204 trial. ...
Posted by Michael Wonder on 09 Jul 2020
Brilinta granted FDA priority review for the reduction of subsequent stroke in patients who had an acute ischaemic stroke or transient ischaemic attack
9 July 2020 - Brilinta in combination with aspirin could be the first FDA approved dual anti-platelet therapy to reduce the ...
Posted by Michael Wonder on 09 Jul 2020
CorMedix reports submission of Defencath new drug application
8 July 2020 - CorMedix today announced that all of the modules for the Defencath new drug application have been submitted ...
Posted by Michael Wonder on 08 Jul 2020
Biogen completes submission of biologics license application to FDA for aducanumab as a treatment for Alzheimer’s disease
8 July 2020 - If approved, aducanumab would be the first treatment with the potential to meaningfully change the course of ...
Posted by Michael Wonder on 02 Jul 2020
scPharmaceuticals announces Furoscix NDA resubmission
1 July 2020 - scPharmaceuticals today announced that it has resubmitted its 505(b)(2) new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 01 Jul 2020
Blueprint Medicines announces submission of new drug application to FDA for pralsetinib for the treatment of advanced RET mutant and RET fusion positive thyroid cancers
1 July 2020 - Blueprint Medicines today announced the submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 01 Jul 2020
Y-mAbs announces initiation of submission of omburtamab rolling biologics license application to the FDA
30 June 2020 - Y-mAbs Therapeutics today announced that the Company has initiated the submission of its biologics license application ...
Posted by Michael Wonder on 01 Jul 2020
Ardelyx announces submission of new drug application to the U.S. FDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
30 June 2020 - Application is supported by three positive Phase 3 clinical trials for tenapanor for hyperphosphataemia, a condition which ...
Posted by Michael Wonder on 01 Jul 2020
Mezzion announces submission of new drug application for its orphan drug udenafil to treat patients who have undergone the Fontan operation for single ventricle heart disease
30 June 2020 - Mezzion Pharma announced today that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 01 Jul 2020
Oncopeptides submits a new drug application to the FDA for accelerated approval of Melflufen in triple-class refractory multiple myeloma patients
30 June 2020 - Oncopeptides today announces that the Company submits a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 30 Jun 2020
MediWound announces submission of biologics license application to the US FDA for NexoBrid for the treatment of severe thermal burns
30 June 2020 - MediWound today announced it has submitted a biologics license application to the US FDA seeking the ...
Posted by Michael Wonder on 29 Jun 2020
Cancer Prevention Pharmaceuticals submits new drug application to the FDA for CPP-1X/sul for treatment of familial adenomatous polyposis
29 June 2020 - Company seeks accelerated approval for cancer drug. ...
Posted by Michael Wonder on 28 Jun 2020
Ascendis Pharma announces submission of biologics license application to FDA for TransCon hGH in paediatric growth hormone deficiency
26 June 2020 - Ascendis Pharma today announced the submission of a biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 25 Jun 2020
Aadi Bioscience initiates rolling submission of NDA to FDA for nab-sirolimus (ABI-009, Fyarro) for the treatment of advanced malignant PEComa
25 June 2020 - Long-term follow-up data released at ASCO 2020 for AMPECT study. ...