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RSS FeedPosted by Michael Wonder on 16 Nov 2017
FDA expands approval of Sutent to reduce the risk of kidney cancer returning
16 November 2017 - FDA approves adjuvant treatment for adult patients at a high risk of kidney cancer returning after nephrectomy. ...
Posted by Michael Wonder on 16 Nov 2017
FDA approves Genentech’s Gazyva for previously untreated advanced follicular lymphoma
16 November 2017 - The first treatment option to demonstrate superior progression-free survival over standard-of-care Rituxan-based therapy. ...
Posted by Michael Wonder on 15 Nov 2017
FDA unveils a streamlined path for the authorisation of tumour profiling tests alongside its latest product action
15 November 2017 - The U.S. FDA today authorised Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer ...
Posted by Michael Wonder on 15 Nov 2017
Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib
15 November 2017 - Faslodex in combination with abemaciclib showed 16.4 months of progression-free survival. ...
Posted by Michael Wonder on 10 Nov 2017
Quality of life: an important element of treatment value
9 November 2017 - In the era of platinum-based chemotherapy, attempts to improve the quality of life of patients with advanced ...
Posted by Michael Wonder on 10 Nov 2017
Seattle Genetics announces FDA approval of Adcetris (brentuximab vedotin) for primary cutaneous anaplastic large cell lymphoma and CD30 expressing mycosis fungoides
9 November 2017 - FDA approval based on clinical trial results from the Phase 3 ALCANZA and Phase 2 investigator-sponsored studies ...
Posted by Michael Wonder on 06 Nov 2017
FDA approves Genentech’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer
6 November 2017 - Approval based on Phase III results that showed Alecensa extended the average time that people lived without ...
Posted by Michael Wonder on 05 Nov 2017
Progenics Pharmaceuticals completes submission of NDA for Azedra (iobenguane I 131) in pheochromocytoma and paraganglioma
2 November 2017 - Progenics Pharmaceuticals announced today that it has completed the rolling submission of its new drug application ...
Posted by Michael Wonder on 03 Nov 2017
GSK’s investigational BCMA antibody-drug conjugate receives breakthrough therapy designation from US FDA for relapsed and refractory multiple myeloma
2 November 2017 - GlaxoSmithKline today announced that it has received breakthrough therapy designation from the U.S. FDA for GSK2857916 monotherapy ...
Posted by Michael Wonder on 01 Nov 2017
Geron announces fast track designation granted to imetelstat for lower risk myelodysplastic syndromes
31 October 2017 - Expanded part 1 of IMerge is open for patient enrolment. ...
Posted by Michael Wonder on 31 Oct 2017
Novartis submits application to FDA for Kymriah (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy
31 October 2017 - Submission based on updated analyses from global, multi-centre Phase II JULIET study, which met primary endpoint, including ...
Posted by Michael Wonder on 31 Oct 2017
FDA approves new treatment for adults with mantle cell lymphoma
31 October 2017 - The U.S. FDA today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle ...
Posted by Michael Wonder on 27 Oct 2017
FDA accepts Genentech’s supplemental biologics license application for Avastin as a front-line treatment for women with advanced ovarian cancer
25 October 2017 - Genentech announced today that the U.S. FDA has accepted the company's supplemental biologics license application for ...
Posted by Michael Wonder on 27 Oct 2017
MorphoSys receives FDA breakthrough therapy designation for its antibody MOR208 in relapsed/refractory DLBCL
23 October 2017 - Designation is intended to expedite development of MorphoSys's most advanced blood cancer drug candidate MOR208 in ...
Posted by Michael Wonder on 23 Oct 2017
Novartis combination adjuvant therapy Tafinlar and Mekinist receives FDA breakthrough therapy designation for stage III BRAF V600 mutation-positive melanoma patients
23 October 2017 - First targeted combination therapy to demonstrate a clinical benefit in patients with a BRAF V600E/K mutation in ...