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RSS FeedPosted by Michael Wonder on 28 Jan 2018
Synthon’s [vic-]trastuzumab duocarmazine (SYD985) granted FDA fast track designation for pre-treated HER2-positive metastatic breast cancer
25 January 2018 - Synthon Biopharmaceuticals today announced that the U.S. FDA has granted fast track designation for its investigational ...
Posted by Michael Wonder on 26 Jan 2018
FDA approves new treatment for certain digestive tract cancers
26 January 2018 - The U.S. FDA today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of ...
Posted by Michael Wonder on 23 Jan 2018
The one year anniversary of the Oncology Center of Excellence
19 January 2018 - One year ago, 19 January 2017, FDA officially launched the Oncology Center of Excellence to leverage the ...
Posted by Michael Wonder on 20 Jan 2018
U.S. FDA grants priority review for daratumumab in front line multiple myeloma
19 January 2018 - 21 May 2018 PDUFA date. ...
Posted by Michael Wonder on 18 Jan 2018
FDA approves addition of overall survival data to Kyprolis (carfilzomib) label
17 January 2018 - Phase 3 data showed Kyprolis and dexamethasone reduced the risk of death by 21% versus Velcade ...
Posted by Michael Wonder on 18 Jan 2018
Aspyrian Therapeutics announces successful advances in RM-1929 clinical development in recurrent head and neck cancer, including fast track designation granted by the FDA
16 January 2018 - Aspyrian plans to initiate pivotal clinical trials for RM-1929 in the first quarter of 2018. ...
Posted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 16 Jan 2018
Teva announces U.S. FDA approval of Trisenox (arsenic trioxide) injection for first-line treatment of acute promyelocytic leukaemia
15 January 2018 - Teva Pharmaceutical Industries announced that the U.S. FDA has approved the use of Trisenox (arsenic trioxide) injection ...
Posted by Michael Wonder on 13 Jan 2018
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
12 January 2018 - The U.S. FDA today expanded the approved use of Lynparza (olaparib) to include the treatment of patients ...
Posted by Michael Wonder on 09 Jan 2018
Eisai and Merck receive breakthrough therapy designation from U.S. FDA for Lenvima (lenvatinib mesylate) and Keytruda (pembrolizumab) as combination therapy for advanced and/or metastatic renal cell carcinoma
9 January 2018 - Eisai and Merck announced today that they received breakthrough therapy designation from the U.S. FDA for Eisai’s ...
Posted by Michael Wonder on 06 Jan 2018
Association of immunotherapy with durable survival as defined by value frameworks for cancer care
28 December 2017 - Modern immuno-oncology agents have generated great excitement because of their potential to provide durable survival for some ...
Posted by Michael Wonder on 03 Jan 2018
Novartis Kisqali received FDA breakthrough therapy designation for initial endocrine-based treatment in pre-menopausal women with HR+/HER2- advanced breast cancer
3 January 2017 - Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine ...
Posted by Michael Wonder on 02 Jan 2018
FDA accepts supplemental biologics license application and grants priority review for Adcetris (brentuximab vedotin) in front-line advanced Hodgkin's lymphoma
2 January 2018 - Submission based on positive results from the Phase 3 ECHELON-1 clinical trial. ...
Posted by Michael Wonder on 29 Dec 2017
Progenics Pharmaceuticals announces FDA acceptance of new drug application for Azedra (iobenguane I 131) in pheochromocytoma and paraganglioma
29 December 2017 - Progenics Pharmaceuticals announced today that the U.S. FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 27 Dec 2017
Agios submits new drug application to the FDA for ivosidenib for the treatment of patients with relapsed/refractory acute myeloid leukaemia and an IDH1 mutation
26 December 2017 - Ivosidenib has potential to be a first-in-class therapy for patients with relapsed/refractory AML and an IDH1 mutation. ...