Blog
RSS FeedPosted by Michael Wonder on 27 Jan 2018
Daliresp receives US FDA approval for 250 mcg starting dose for patients with severe COPD
24 January 2018 - Study shows Daliresp 250 mcg as a starting dose for the first four weeks followed by 500 ...
Posted by Michael Wonder on 26 Jan 2018
FDA approves new treatment for certain digestive tract cancers
26 January 2018 - The U.S. FDA today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of ...
Posted by Michael Wonder on 26 Jan 2018
Synergy Pharmaceuticals announces FDA approval of Trulance (plecanatide) for the treatment of irritable bowel syndrome with constipation in adults
25 January 2017 - Synergy Pharmaceuticals announced today that the U.S. FDA has approved Trulance (plecanatide) 3 mg tablet for the ...
Posted by Michael Wonder on 24 Jan 2018
Characteristics of interim publications of randomised clinical trials and comparison with final publications
23 January 2018 - Publication of interim results of randomised trials can be consequential, potentially undermining trial integrity by unblinding or ...
Posted by Michael Wonder on 23 Jan 2018
FDA accepts investigational new drug application and grants fast track status for SOBI003 for the treatment of MPS IIIA
23 January 2018 - Swedish Orphan Biovitrum announces that the FDA has issued a study may proceed letter for the ...
Posted by Michael Wonder on 23 Jan 2018
The one year anniversary of the Oncology Center of Excellence
19 January 2018 - One year ago, 19 January 2017, FDA officially launched the Oncology Center of Excellence to leverage the ...
Posted by Michael Wonder on 23 Jan 2018
Baxter announces U.S. FDA approval of ready-to-use cardiovascular medication bivalirudin
22 January 2018 - First presentation of bivalirudin in frozen, premixed, ready-to-use formulation. ...
Posted by Michael Wonder on 22 Jan 2018
Braeburn receives complete response letter for CAM2038 injectable buprenorphine depot for the treatment of opioid use disorder
21 January 2018 - Braeburn Pharmaceuticals today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 20 Jan 2018
U.S. FDA grants priority review for daratumumab in front line multiple myeloma
19 January 2018 - 21 May 2018 PDUFA date. ...
Posted by Michael Wonder on 20 Jan 2018
The FDA should shine more light on drug rejections
19 January 2018 - The status quo helps companies doll up failures, hurting investors and public health. ...
Posted by Michael Wonder on 19 Jan 2018
Aquestive Therapeutics announces U.S. FDA filing acceptance of new drug application for clobazam oral soluble film to treat Lennox-Gastaut syndrome
18 January 2018 - Aquestive Therapeutics today announced that the U.S. FDA has accepted for review the company’s new drug application ...
Posted by Michael Wonder on 19 Jan 2018
Drug maker raises U.S. price of muscular dystrophy treatment
18 January 2018 - Cost of drug Emflaza, which came under scrutiny last year, will go up by 9% for regular ...
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 18 Jan 2018
Lyric Pharma granted FDA fast track designation for lead product ulimorelen for enteral feeding intolerance
17 January 2018 - Lyric Pharmaceuticals today announced that the United States FDA has granted fast track designation to the investigation ...
Posted by Michael Wonder on 18 Jan 2018
FDA approves addition of overall survival data to Kyprolis (carfilzomib) label
17 January 2018 - Phase 3 data showed Kyprolis and dexamethasone reduced the risk of death by 21% versus Velcade ...