Blog
RSS FeedPosted 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 02 Jul 2020
Reduced annual charges for medical devices listed on the prostheses list
2 July 2020 - In response to the suspension of elective surgery due to COVID-19 and the significant impact this has ...
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
International regulators provide guiding principles for COVID-19 clinical trials
1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...
Posted by Michael Wonder on 01 Jul 2020
Medicines Australia welcomes support for national harmonisation of clinical trials
30 June 2020 - Medicines Australia welcomes the announcement from the Minister for Health, the Hon Greg Hunt MP, during ...
Posted 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
EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
30 June 2020 - EMA and the Ministry of Food and Drug Safety of the Republic of Korea have signed ...