Blog
RSS FeedPosted by Michael Wonder on 13 May 2019
Lilly's Cyramza (ramucirumab) becomes first FDA approved biomarker-driven therapy in patients with hepatocellular carcinoma
13 May 2019 - This new indication - the fifth FDA approval for Cyramza in an advanced or metastatic cancer - ...
Posted by Michael Wonder on 08 May 2019
FDA grants CytoDyn fast track designation for leronlimab (PRO 140) in metastatic triple-negative breast cancer, an unmet medical need
7 May 2019 - CytoDyn today announced that the U.S. FDA has granted fast track designation to leronlimab (PRO140) for ...
Posted by Michael Wonder on 04 May 2019
FDA approves Genentech's Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment
3 May 2019 - Application approved under FDA’s real-time oncology review pilot program. ...
Posted by Michael Wonder on 03 May 2019
Agios announces FDA approval of supplemental new drug application for Tibsovo as monotherapy for newly diagnosed adult patients with IDH1 mutant acute myeloid leukaemia not eligible for intensive chemotherapy
2 May 2019 - Approval based on 28 newly diagnosed patients from Phase 1 study of Tibsovo in advanced haematologic ...
Posted by Michael Wonder on 02 May 2019
Substandard control arms question the utility of some new cancer drugs
2 May 2019 - The rapid pace of new cancer drugs approved by the FDA, 16 in 2018 alone, is ...
Posted by Michael Wonder on 01 May 2019
Janssen submits application to U.S. FDA seeking approval of Erleada (apalutamide) for patients with metastatic castration-sensitive prostate cancer
29 April 2019 - Supplemental new drug application supported by Phase 3 TITAN study; submitted through FDA real-time oncology review program. ...
Posted by Michael Wonder on 25 Apr 2019
Lilly to establish an access program for patients as it prepares to withdraw Lartruvo from the global market
25 April 2019 - Lilly is working to ensure current patients access to Lartruvo with limited interruption after it is ...
Posted by Michael Wonder on 23 Apr 2019
Intensity Therapeutics receives fast track designation from U.S. FDA for development of INT230-6 as treatment for relapsed or metastatic triple negative breast cancer
17 April 2019 - Intensity Therapeutics today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 23 Apr 2019
FDA approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
22 April 2019 - Approval based on results of KEYNOTE-426, where Keytruda in combination with axitinib reduced the risk of death ...
Posted by Michael Wonder on 21 Apr 2019
Moleculin receives FDA approval of fast track designation for annamycin
18 April 2019 - Moleculin Biotech today announced that the U.S. FDA has approved its request for fast track designation ...
Posted by Michael Wonder on 16 Apr 2019
Aprea Therapeutics receives FDA fast track designation and orphan drug designation for APR-246 for the treatment of myelodysplastic syndromes
16 April 2019 - Aprea Therapeutics today announced that the U.S. FDA has granted fast track designation to APR-246 for ...
Posted by Michael Wonder on 13 Apr 2019
FDA approves first targeted therapy for metastatic bladder cancer
12 April 2019 - The U.S. FDA today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally ...
Posted by Michael Wonder on 12 Apr 2019
FDA approves expanded monotherapy label for Merck’s Keytruda (pembrolizumab)
11 April 2019 - Keytruda now approved for first-line treatment of patients with Stage III NSCLC who are not candidates for ...
Posted by Michael Wonder on 07 Apr 2019
Celgene Corporation and Acceleron Pharma announce submission of luspatercept biologics license application to U.S. FDA
5 April 2019 - Submission includes both myelodysplastic syndromes and beta-thalassemia indications. ...
Posted by Michael Wonder on 04 Apr 2019
Daiichi Sankyo provides update on ongoing FDA review for quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
4 April 2019 - Daiichi Sankyo today announced that the U.S. FDA has extended the review period for the new ...