Blog
RSS FeedPosted by Michael Wonder on 01 Jul 2020
FDA approves Bavencio as first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma
30 June 2020 - First and only FDA approved immunotherapy to demonstrate a significant overall survival benefit in the first-line setting ...
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
Sun BioPharma receives FDA fast track designation for SBP-101
30 June 2020 - Sun BioPharma today announced receipt of fast track designation from the U.S. FDA for its lead product, ...
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 30 Jun 2020
Ultragenyx announces U.S. FDA approval of Dojolvi (UX007/triheptanoin), the first FDA approved therapy for the treatment of long-chain fatty acid oxidation disorders
30 June 2020 - Fourth U.S. FDA approval for Ultragenyx in the past three years – all for rare diseases which ...
Posted by Michael Wonder on 30 Jun 2020
FDA takes action to help facilitate timely development of safe, effective COVID-19 vaccines
30 June 2020 - Today, the U.S. FDA took important action to help facilitate the timely development of safe and effective ...
Posted by Michael Wonder on 30 Jun 2020
Nordic Nanovector's Betalutin receives fast track designation from US FDA for marginal zone lymphoma
29 June 2020 - Nordic Nanovector today announces that the US FDA has granted fast track designation for investigating Betalutin (177Lu ...
Posted by Michael Wonder on 30 Jun 2020
Heron Therapeutics receives complete response letter for HTX-011 for the management of post-operative pain
29 June 2020 - Complete response letter requests additional non-clinical information. ...
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 29 Jun 2020
Gilead sets price for coronavirus drug remdesivir at $2,340, sparking criticism
30 June 2020 - The maker of a drug shown to shorten recovery time for severely ill COVID-19 patients says ...
Posted by Michael Wonder on 29 Jun 2020
FDA approves first-line immunotherapy for patients with MSI-H/dMMR metastatic colorectal cancer
26 June 2020 - Today, the U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment ...
Posted by Michael Wonder on 29 Jun 2020
FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer
29 June 2020 - Today the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf ...