Blog
RSS FeedPosted 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
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
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
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 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
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 ...
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. ...
Posted by Michael Wonder on 24 Jun 2020
FDA approves pembrolizumab for cutaneous squamous cell carcinoma
24 June 2020 - Today the FDA approved pembrolizumab (Keytruda, Merck & Co) for patients with recurrent or metastatic cutaneous ...
Posted by Michael Wonder on 23 Jun 2020
Polynoma receives FDA fast track designation for its melanoma cancer vaccine seviprotimut-L
23 June 2020 - Polynoma announces that the U.S. FDA has granted its application for fast track designation of seviprotimut-L, ...
Posted by Michael Wonder on 23 Jun 2020
FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials
23 June 2020 - The U.S. FDA today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence. ...
Posted by Michael Wonder on 23 Jun 2020
Imbruvica (ibrutinib) seeks to expand U.S. label with long-term data in Waldenström's macroglobulinaemia
23 June 2020 - Submission is based on results of more than five years of follow-up data from the Phase 3 ...
Posted by Michael Wonder on 23 Jun 2020
Myovant Sciences announces priority review and FDA acceptance of new drug application for once daily, oral relugolix for advanced prostate cancer
22 June 2020 - Priority review status expected to accelerate review, with a target FDA action date of 20 December ...