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RSS FeedPosted by Michael Wonder on 15 May 2018
Aerie Pharmaceuticals submits new drug application to U.S. FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
15 May 2018 - Submitted as a 505(b)(2) with an expected ten month FDA review. ...
Posted by Michael Wonder on 25 Apr 2018
Once daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD
24 April 2018 - GlaxoSmithKline Innoviva today announced that the US FDA has approved an expanded indication for Trelegy Ellipta (fluticasone ...
Posted by Michael Wonder on 21 Apr 2018
Helsinn Group announces the FDA approval of the IV formulation of Akynzeo (fosnetupitant/palonosetron) in the United States
20 April 2018 - Helsinn today announces that the U.S. FDA has approved the intravenous formulation of Akynzeo (NEPA, a ...
Posted by Michael Wonder on 29 Mar 2018
Mylan introduces Symfi triple combo once-daily HIV treatment in the U.S.
28 March 2018 - All ARV regimens are being offered at a significant discount to the price of competing products to ...
Posted by Michael Wonder on 12 Mar 2018
Hikma provides an update on the status of its ANDA for generic Advair Diskus
12 March 2018 - Hikma Pharmaceuticals announces that it is has received a response from the United States FDA in ...
Posted by Michael Wonder on 24 Feb 2018
KemPharm announces FDA approval of Apadaz (benzhydrocodone and paracetamol) for the short-term management of acute pain
23 February 2018 - Apadaz is the first pro-drug of hydrocodone/paracetamol to be approved by FDA. ...
Posted by Michael Wonder on 21 Feb 2018
Mylan receives tentative approval for combination HIV treatment DTG/FTC/TAF under FDA's PEPFAR program
20 February 2018 - Mylan's DTG/FTC/TAF will be the first TAF-based fixed-dose combination to be offered to patients in developing ...
Posted by Michael Wonder on 13 Feb 2018
FDA approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to treat the underlying cause of cystic fibrosis in people ages 12 and older with certain mutations in the CFTR gene
12 February 2018 - Symdeko to begin shipping to pharmacies this week. ...
Posted by Michael Wonder on 08 Feb 2018
U.S. FDA approves Gilead’s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for treatment of HIV-1 infection
7 February 2018 - In clinical trials, Biktarvy demonstrated high efficacy, few interactions with other drugs and a high barrier to ...
Posted by Michael Wonder on 02 Feb 2018
FDA approves Avycaz (ceftazidime and avibactam) for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
1 February 2018 - First gram-negative antibiotic approved in the U.S. to treat HABP/VABP in over 15 years. ...
Posted by Michael Wonder on 19 Jan 2018
Avion Pharmaceuticals announces approval of first NDA in the oral contraceptive category
18 January 2018 - Avion Pharmaceuticals received approval of its new drug application for the oral contraceptive Balcoltra (levonorgestrel and ...
Posted by Michael Wonder on 13 Dec 2017
Omeros Corporation announces FDA approval of Omidria for use in paediatric patients
12 December 2017 - FDA also grants additional market exclusivity. ...
Posted by Michael Wonder on 30 Nov 2017
FDA approves Ferring’s Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for colonoscopy prep
29 November 2017 - New ready-to-drink low-volume colonoscopy prep in a pre-mixed liquid solution. ...
Posted by Michael Wonder on 23 Nov 2017
GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta
23 November 2017 - GlaxoSmithKline and Innoviva today announced the filing of a supplemental new drug application with the US FDA ...
Posted by Michael Wonder on 21 Nov 2017
FDA approves first two-drug regimen for certain patients with HIV
21 November 2017 - FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with ...