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RSS FeedPosted by Michael Wonder on 30 Nov 2016
Curis announces full approval of Roche's Erivedge in the European Union
28 November 2016 - Curis today announced that the EMA CHMP has granted full approval to Erivedge (vismodegib) for the ...
Posted by Michael Wonder on 30 Nov 2016
Ariad announces FDA full approval and label update for Iclusig (ponatinib) based on long-term efficacy and safety data from Phase 2 PACE clinical trial
29 November 2016 - Full approval granted through completion of accelerated approval commitments for rare cancer patients who may have ...
Posted by Michael Wonder on 26 Nov 2016
Important new cancer treatments approved by Health Canada marred by major provincial reality disconnect for patients
22 November 2016 - Health Canada recently conditionally approved an advanced new treatment option for Canadians battling metastatic melanoma. ...
Posted by Michael Wonder on 25 Nov 2016
Ninlaro (ixazomib citrate) receives conditional approval from the European Commission to treat multiple myeloma
24 November 2016 - Approval based on TOURMALINE-MM1 study results, which demonstrated statistically significant six-month improvement in progression-free survival. ...
Posted by Michael Wonder on 24 Nov 2016
Eli Lilly’s experimental Alzheimer’s drug fails in large trial
23 November 2016 - An experimental Alzheimer’s drug that had previously appeared to show promise in slowing the deterioration of ...
Posted by Michael Wonder on 23 Nov 2016
TGA approves extended use of Harvoni
23 November 2016 - The TGÅ has approved the use of Harvoni in additional genotypes. ...
Posted by Michael Wonder on 23 Nov 2016
CHMP adopts positive opinion for Zinplava
23 November 2016 - Bezlotoxumab is a human monoclonal anti-toxin antibody that binds with high affinity to Clostridium difficile toxin ...
Posted by Michael Wonder on 23 Nov 2016
Belsomra finally approved by TGA
23 November 2016 - The TGA has approved MSD's orexin receptor antagonist. ...
Posted by Michael Wonder on 23 Nov 2016
Halaven cleared by TGA for sarcoma
23 November 2016 - Eisai bags a second use for its halichondrin B analogue. ...
Posted by Michael Wonder on 23 Nov 2016
TGA approves another Opdivo for another cancer type
23 November 2016 - The TGA has sanctioned the use of nivolumab for use by patients with renal cell carcinoma. ...
Posted by Michael Wonder on 22 Nov 2016
European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin
22 November 2016 - First and only PD-1 inhibitor approved for a haematologic malignancy in the European Union. ...
Posted by Michael Wonder on 22 Nov 2016
Sanofi receives FDA approval of Soliqua 100/33, for the treatment of adults with type 2 diabetes
21 November 2016 - Sanofi announced today that the U.S. FDA approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) ...
Posted by Michael Wonder on 22 Nov 2016
Mallinckrodt will initiate company-sponsored clinical trial of H.P. Acthar Gel in treatment of amyotropic lateral sclerosis
21 November 2016 - Investigational new drug application for use of H.P Acthar Gel in amyotropic lateral sclerosis awarded fast ...
Posted by Michael Wonder on 22 Nov 2016
U.S. FDA grants fast track designation for the development of Oragenics’ AG013 for oral mucositis
21 November 2016 - Oragenics today announced that the U.S. FDA granted fast track designation to AG013, the Company’s lead ...
Posted by Michael Wonder on 22 Nov 2016
Novo Nordisk receives US FDA approval for Xultophy 100/3.6
21 November 2016 - Novo Nordisk today announced that the US FDA has approved the new drug application for Xultophy 100/3.6. ...