Blog
RSS FeedPosted by Michael Wonder on 07 Dec 2018
FDA approves Genentech’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer
6 December 2018 - Approval based on survival benefit of Tecentriq, in combination with Avastin, paclitaxel and carboplatin (chemotherapy), in people ...
Posted by Michael Wonder on 05 Dec 2018
FDA grants priority review to Genentech’s Tecentriq in combination with chemotherapy for the initial treatment of extensive-stage small cell lung cancer
4 December 2018 - Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 29 Nov 2018
FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukaemia with a certain genetic mutation
28 November 2018 - The U.S. FDA today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed ...
Posted by Michael Wonder on 28 Nov 2018
FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma
28 November 2018 - The agency has now approved 15 biosimilars and is advancing new policies to improve the efficiency of ...
Posted by Michael Wonder on 27 Nov 2018
Loxo and Bayer's amazing drug has an expensive price
26 November 2018 - A little more than a year ago, I wrote the story of a cancer drug developed by ...
Posted by Michael Wonder on 26 Nov 2018
FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumour
26 November 2018 - The U.S. FDA today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and paediatric ...
Posted by Michael Wonder on 22 Nov 2018
FDA grants priority review for Daiichi Sankyo’s new drug application for FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
22 November 2018 - Quizartinib marketing applications now under expedited review in the U.S., Japan and EU. ...
Posted by Michael Wonder on 21 Nov 2018
AbbVie receives US FDA accelerated approval for Venclexta (venetoclax) for treatment of newly-diagnosed acute myeloid leukaemia patients ineligible for intensive chemotherapy
21 November 2018 - The approval in AML is the third provided under priority review by the U.S. FDA for Venclexta, ...
Posted by Michael Wonder on 21 Nov 2018
FDA approves new treatment for patients with acute myeloid leukaemia
21 November 2018 - The U.S. FDA today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine, for ...
Posted by Michael Wonder on 16 Nov 2018
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
16 November 2018 - The U.S. FDA today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy ...
Posted by Michael Wonder on 16 Nov 2018
FDA grants breakthrough therapy designation to Adcetris (brentuximab vedotin) for frontline peripheral T-cell lymphomas
15 November 2018 - Designation based on positive Phase 3 ECHELON-2 Trial evaluating Adcetris in frontline CD30-expressing peripheral T-cell lymphomas. ...
Posted by Michael Wonder on 13 Nov 2018
FDA grants priority review to Roche’s Tecentriq in combination with Abraxane for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer
13 November 2018 - If approved, this Tecentriq (atezolizumab) combination would be the first cancer immunotherapy regimen for the treatment ...
Posted by Michael Wonder on 12 Nov 2018
US FDA accepts regulatory submission for Lynparza maintenance therapy in newly-diagnosed, BRCA mutated advanced ovarian cancer and grants priority review
12 November 2018 - First US regulatory submission acceptance for a PARP inhibitor as a first-line maintenance treatment for advanced ...
Posted by Michael Wonder on 10 Nov 2018
Karyopharm’s selinexor receives fast track designation from FDA for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma
7 November 2018 - Karyopharm Therapeutics today announced that the U.S. FDA has granted fast track designation to selinexor, the Company’s ...
Posted by Michael Wonder on 10 Nov 2018
FDA approves Merck’s Keytruda (pembrolizumab) for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib
10 November 2018 - Approval marks 14th indication for Keytruda. ...