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RSS FeedPosted by Michael Wonder on 03 Aug 2017
FDA approves first treatment for certain types of poor-prognosis acute myeloid leukaemia
3 August 2017 - The U.S. FDA today approved Vyxeos for the treatment of adults with two types of acute myeloid ...
Posted by Michael Wonder on 03 Aug 2017
US FDA accepts regulatory submission for acalabrutinib and grants priority review
2 August 2017 - AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the ...
Posted by Michael Wonder on 01 Aug 2017
FDA approves new targeted treatment for relapsed or refractory acute myeloid leukaemia
1 August 2017 - The U.S. FDA today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory ...
Posted by Michael Wonder on 01 Aug 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) in MSI-H or dMMR metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
1 August 2017 - Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% (95% CI: ...
Posted by Michael Wonder on 01 Aug 2017
Acalabrutinib granted breakthrough therapy designation by US FDA for the treatment of patients with mantle cell lymphoma
1 August 2017 - AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US ...
Posted by Michael Wonder on 31 Jul 2017
Imfinzi granted breakthrough therapy designation by US FDA for patients with locally-advanced unresectable non-small-cell lung cancer
31 July 2017 - Fourth breakthrough therapy designation for an AstraZeneca new oncology medicine in three years. ...
Posted by Michael Wonder on 30 Jul 2017
Roche leukaemia drug gets FDA breakthrough therapy designation
28 July 2017 - Roche Holding AG's Venclexta has won breakthrough therapy designation in acute myeloid leukaemia from the U.S. ...
Posted by Michael Wonder on 29 Jul 2017
Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?
26 July 2017 - Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to ...
Posted by Michael Wonder on 24 Jul 2017
U.S. FDA accepts Bristol-Myers Squibb’s applications for Opdivo (nivolumab) four-week dosing schedule across all approved indications
24 July 2017 - Bristol-Myers Squibb today announced that the U.S. FDA accepted its supplemental biologics license applications to update ...
Posted by Michael Wonder on 24 Jul 2017
Companies rush to develop ‘utterly transformative’ gene therapies
23 July 2017 - The approval of gene therapy for leukaemia, expected in the next few months, will open the ...
Posted by Michael Wonder on 24 Jul 2017
U.S. FDA expands approval of Yervoy (ipilimumab) to include paediatric patients 12 years and older with unresectable or metastatic melanoma
24 July 2017 - First Bristol-Myers Squibb immuno-oncology approval for adolescents 12 years and older reflects the company’s commitment to the ...
Posted by Michael Wonder on 17 Jul 2017
FDA approves new treatment to reduce the risk of breast cancer returning
17 July 2017 - The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, ...
Posted by Michael Wonder on 11 Jul 2017
What to watch for as Novartis heads to the FDA with a novel cancer therapy
10 July 2017 - The FDA has weighed in on Novartis’ pioneering personalized cancer therapy, which looks almost certain to ...
Posted by Michael Wonder on 10 Jul 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Sprycel (dasatinib) in children with Philadelphia chromosome positive chronic phase chronic myeloid leukaemia
10 July 2017 - Application is based on results from Phase 2 CA180-226 study. ...
Posted by Michael Wonder on 10 Jul 2017
FDA grants priority review for Lilly's abemaciclib for the treatment of advanced breast cancer
10 July 2017 - Eli Lilly and Company (NYSE: LLY) today announced that the U.S. FDA has accepted and filed its ...