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RSS FeedPosted by Michael Wonder on 28 Dec 2017
Horizon Pharma announces FDA approval to expand the indication for Procysbi (cysteamine bitartrate) delayed-release capsules to include children one year of age and older living with nephropathic cystinosis
27 December 2017 - Horizon Pharma today announced the U.S. FDA has approved an expansion to the indication for Procysbi (cysteamine ...
Posted by Michael Wonder on 28 Dec 2017
Sun Pharma announces US FDA acceptance of NDA for OTX-101
27 December 2017 - OTX-101 is being evaluated for treatment of dry eye disease. ...
Posted by Michael Wonder on 28 Dec 2017
Portola Pharmaceuticals provides update on biologics license application for AndexXa (andexanet alfa)
22 December 2017 - Portola Pharmaceuticals today announced that the U.S. FDA will extend its review of the biologics license application ...
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. ...
Posted by Michael Wonder on 27 Dec 2017
DelMar Pharmaceuticals announces fast track designation for VAL-083 in recurrent glioblastoma
26 December 2017 - Supports lead program, VAL-083, in on-going clinical trials. ...
Posted by Michael Wonder on 27 Dec 2017
FDA grants Insys Therapeutics ‘fast track’ designation for cannabidiol oral solution as investigational treatment for Prader-Willi syndrome
26 December 2017 - INSYS Therapeutics announced today that the U.S. FDA has granted fast track designation to the company’s cannabidiol ...
Posted by Michael Wonder on 26 Dec 2017
Cancer drug price rises 1,400% with no generic to challenge it
25 December 2017 - Lomustine among 319 drugs with expired patents but no copies; FDA trying to boost competition. ...
Posted by Michael Wonder on 26 Dec 2017
Six health stories to watch in 2018
24 December 2017 - A new year could bring new treatments for migraines and breast cancer, greater access to a powerful ...
Posted by Michael Wonder on 23 Dec 2017
Many FDA approved cancer drugs might lack clinical benefit
21 December 2017 - New research shows that less than half of the randomised controlled trials that support the approval of ...
Posted by Michael Wonder on 23 Dec 2017
Agile Therapeutics receives a complete response letter from the FDA for Twirla (AG200-15) for the prevention of pregnancy
22 December 2017 - Agile Therapeutics today announced that the U.S. FDA issued a complete response letter in response to ...
Posted by Michael Wonder on 23 Dec 2017
BioMarin receives anticipated notification of PDUFA extension for pegvaliase biologics license application to 28 May 2018
22 December 2017 - Regulatory review process proceeding in-line with company's expectations. ...
Posted by Michael Wonder on 23 Dec 2017
Santen receives complete response letter from U.S. FDA for intravitreal sirolimus (DE-109)
21 December 2017 - Santen Pharmaceutical today announced that the U.S. FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 22 Dec 2017
FDA updates the label of Tasigna to reflect that certain patients with a type of leukaemia may be eligible to stop treatment after sustained response
22 December 2017 - Discontinuation in treatment marks a first in chronic myeloid leukaemia. ...
Posted by Michael Wonder on 22 Dec 2017
Novartis' combination therapy Tafinlar and Mekinist granted FDA priority review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma
22 December 2017 - Priority review designation based on Phase III study showing 53% reduction in risk of recurrence or death ...
Posted by Michael Wonder on 22 Dec 2017
Mesoblast receives FDA regenerative medicine advanced therapy designation for its cell therapy in heart failure patients with left ventricular assist devices
21 December 2017 - Mesoblast today announced that the United States FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ...