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RSS FeedPosted by Michael Wonder on 27 Feb 2019
Iovance Biotherapeutics was granted fast track designation for LN-145 for cervical cancer
26 February 2019 - Iovance Biotherapeutics today announced that the U.S. FDA has granted fast track designation for LN-145 for the ...
Posted by Michael Wonder on 26 Feb 2019
The FDA's Oncology Center of Excellence — quantifying the patient experience
23 February 2019 - Cancer therapies are typically evaluated based on their ability to control the growth of a tumor ...
Posted by Michael Wonder on 25 Feb 2019
FDA approves Taiho Oncology's Lonsulf (trifluridine/tipiracil) for adult patients with previously treated advanced gastric or gastro-esophageal junction (GEJ) Adenocarcinoma
25 February 2019 - Taiho Oncology today announced that the United States FDA has approved Lonsulf as a treatment for adult ...
Posted by Michael Wonder on 20 Feb 2019
Agios announces FDA acceptance of supplemental new drug application for Tibsovo (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukaemia with an IDH1 mutation not eligible for standard therapy
20 February 2019 - PDUFA date set for June 21 2019. ...
Posted by Michael Wonder on 20 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) monotherapy for third-line treatment of patients with advanced small cell lung cancer
20 February 2019 - Marks first application for Keytruda in SCLC. ...
Posted by Michael Wonder on 20 Feb 2019
FDA approves Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection
19 February 2019 - U.S. approval based on significant recurrence-free survival benefit demonstrated with Keytruda in Phase 3 EORTC1325/KEYNOTE-054 trial. ...
Posted by Michael Wonder on 20 Feb 2019
FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma
19 February 2019 - Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease. ...
Posted by Michael Wonder on 19 Feb 2019
FDA grants priority review to Roche’s personalised medicine entrectinib
19 February 2019 - Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug ...
Posted by Michael Wonder on 16 Feb 2019
OncoGenex announces fast track designation granted for custirsen in combination with cabazitaxel/prednisone as second-line chemotherapy in Phase 3 AFFINITY trial of men with metastatic castrate-resistant prostate cancer
23 April 2014 - Third Phase 3 trial of custirsen to receive FDA fast track designation. ...
Posted by Michael Wonder on 16 Feb 2019
Tokai Pharmaceuticals’ galeterone receives fast track designation from the FDA for the treatment of advanced prostate cancer
12 June 2012 - Tokai Pharmaceuticals today announced that its lead candidate, galeterone (TOK-001), has received fast track designation from ...
Posted by Michael Wonder on 16 Feb 2019
Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer meets primary endpoint
24 October 2018 - Bayer has been granted fast track designation by the U.S. FDA for darolutamide in men with nmCRPC. ...
Posted by Michael Wonder on 16 Feb 2019
Innocrin Pharmaceuticals granted fast track designation by FDA for VT-464 treatment of patients with metastatic castrate-resistant prostate cancer
6 January 2016 - Seviteronel to be presented in three sessions at the ASCO Genitourinary Cancer Symposium to be held in ...
Posted by Michael Wonder on 16 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for advanced renal cell carcinoma
15 February 2019 - Application based on overall survival and progression-free survival data from Phase 3 KEYNOTE-426 trial. ...
Posted by Michael Wonder on 13 Feb 2019
Lynparza (olaparib) granted breakthrough therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer
28 January 2016 - AstraZeneca today announced that the US FDA has granted breakthrough therapy designation for the oral poly ...
Posted by Michael Wonder on 13 Feb 2019
Genmab announces U.S. FDA approval of Darzalex (daratumumab) split dosing regimen
12 February 2019 - Provides healthcare professionals with option to split first Darzalex infusion over two consecutive days. ...