Blog
RSS FeedPosted by Michael Wonder on 12 Oct 2017
U.S. FDA accepts for review Astellas’ supplemental new drug application for mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder
12 September 2017 - If approved, the combination therapy could potentially offer a new treatment option for patients whose overactive ...
Posted by Michael Wonder on 04 Oct 2017
FDA accepts supplemental new drug application filing for Avycaz (ceftazidime and avibactam)
2 October 2017 - Application seeks to expand label to include an indication and phase 3 data for the treatment of ...
Posted by Michael Wonder on 28 Sep 2017
Lannett receives FDA approval for oxycodone and acetaminophen tablets, 5 mg/325 mg and 10 mg/325 mg
27 September 2017 - Lannett today announced that it received approval from the U.S. FDA of its abbreviated new drug ...
Posted by Michael Wonder on 19 Sep 2017
Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US
18 September 2017 - GSK and Innoviva today announced that the FDA has approved once-daily, single inhaler triple therapy fluticasone ...
Posted by Michael Wonder on 25 Aug 2017
Vertex announces acceptance of its applications for review of the tezacaftor/ivacaftor combination treatment in people with cystic fibrosis by the FDA and EMA
24 August 2017 - FDA grants priority review of the application and sets action date of 28 February 2018. ...
Posted by Michael Wonder on 22 Aug 2017
Alkermes initiates rolling submission of ALKS 5461 new drug application for major depressive disorder
21 August 2017 - Company expects to complete submission for fast track designated medicine by year-end 2017. ...
Posted by Michael Wonder on 22 Aug 2017
Ironwood Pharmaceuticals announces FDA approval of Duzallo (lesinurad and allopurinol) for the treatment of hyperuricaemia in patients with uncontrolled gout
21 August 2017 - Once daily Duzallo is the first FDA approved fixed-dose combination treatment that addresses both causes of ...
Posted by Michael Wonder on 12 Aug 2017
Gilead announces U.S. FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV
10 August 2017 - Final FDA Decision Anticipated by 12 February 2018. ...
Posted by Michael Wonder on 03 Aug 2017
FDA approves Mavyret for Hepatitis C
3 August 2017 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus ...
Posted 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
U.S. FDA approves expanded labeling for Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C in patients co-infected with HIV
1 August 2017 - New data for first approved pan-genotypic once-daily single tablet regimen for chronic hepatitis C virus infection. ...
Posted by Michael Wonder on 18 Jul 2017
FDA approves Vosevi for hepatitis C
18 July 2017 - The U.S. FDA today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 ...
Posted by Michael Wonder on 04 Jul 2017
Amphora (L-lactic acid, citric acid, and potassium bitartrate) receives QIDP designation from the FDA
29 June 2017 - Designation includes two separate indications and provides eligibility for priority review and additional exclusivity. ...
Posted by Michael Wonder on 02 Jul 2017
Astellas submits supplemental new drug application for mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder
30 June 2017 - Astellas announced today the submission of a supplemental new drug application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 15 Jun 2017
FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus
15 June 2017 - Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference ...