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RSS FeedPosted by Michael Wonder on 08 Dec 2020
Turning Point Therapeutics granted FDA breakthrough therapy designation for repotrectinib treatment in patients with ROS1 positive metastatic non-small cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor
8 December 2020 - Updated data from TRIDENT-1 study in tyrosine kinase inhibitor naïve patients with ROS1 positive non-small cell lung ...
Posted by Michael Wonder on 07 Dec 2020
Immunicum receives FDA fast track designation for ilixadencel in gastro-intestinal stromal tumours
7 December 2020 - Immunicum announced today that it has received fast track designation from the U.S. FDA for the Company’s ...
Posted by Michael Wonder on 04 Dec 2020
enGene receives fast track designation for EG-70 for the treatment of non-muscle invasive bladder cancer
3 December 2020 - enGene announced today that the U.S. FDA has granted fast track designation to enGene for EG-70, the ...
Posted by Michael Wonder on 03 Dec 2020
Genmab announces that Janssen has submitted a biologics license application to U.S. FDA for amivantamab in non-small cell lung cancer
3 December 2020 - First regulatory submission for a DuoBody product candidate. ...
Posted by Michael Wonder on 03 Dec 2020
The real worth of cancer drugs
1 December 2020 - In November, 2020, we witnessed one of the most awaited elections in recent times—the USA elected Joe ...
Posted by Michael Wonder on 03 Dec 2020
Moleculin announces FDA approves 3 rare paediatric disease designations for WP1066
1 December 2020 - Moleculin Biotech today announced that the US FDA has approved its request for a rare paediatric ...
Posted by Michael Wonder on 02 Dec 2020
BridgeBio Pharma and Affiliate QED Therapeutics announce FDA acceptance of new drug application for infigratinib for the treatment of cholangiocarcinoma
1 December 2020 - Application will also be submitted for review in Australia and Canada under Project Orbis. ...
Posted by Michael Wonder on 02 Dec 2020
TG Therapeutics initiates rolling submission of biologics license application to U.S. FDA for ublituximab in combination with umbralisib as a treatment for patients with chronic lymphocytic leukaemia
1 December 2020 - Completion of rolling submission for the BLA expected in 1H21. ...
Posted by Michael Wonder on 01 Dec 2020
Ipsen receives FDA fast track designation for investigational irinotecan liposome injection (Onivyde) as a second-line monotherapy treatment for small cell lung cancer
30 November 2020 - Ipsen today announced the United States FDA has granted the company fast track designation for irinotecan liposome ...
Posted by Michael Wonder on 01 Dec 2020
FDA approves pralsetinib for RET altered thyroid cancers
1 December 2020 - Today the Food and Drug Administration approved pralsetinib (Gavreto, Blueprint Medicines) for adult and pediatric patients ...
Posted by Michael Wonder on 01 Dec 2020
FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer
1 December 2020 - Today, the U.S. FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for ...
Posted by Michael Wonder on 01 Dec 2020
Karolinska Development's portfolio company Aprea Therapeutics receives FDA fast track designation for eprenetapopt in AML
30 November 2020 - Karolinska Development announces today that the U.S. FDA has granted fast track designation for eprenetapopt in the ...
Posted by Michael Wonder on 30 Nov 2020
Zymeworks receives FDA breakthrough therapy designation for HER2-targeted bispecific antibody zanidatamab in patients with biliary tract cancer
30 November 2020 - Zymeworks today announced that the U.S. FDA has granted breakthrough therapy designation for zanidatamab in patients with ...
Posted by Michael Wonder on 25 Nov 2020
FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow
25 November 2020 - On 24 November 2020, the FDA granted accelerated approval to naxitamab (Danyelza, Y-mAbs Therapeutics) in combination with ...
Posted by Michael Wonder on 25 Nov 2020
RhoVac's prostate cancer drug candidate RV001 is granted fast track designation by the FDA
25 November 2020 - RhoVac, a clinical stage company today announced that the American FDA has granted Fast Track Designation to ...