Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 18 Jan 2018
Aspyrian Therapeutics announces successful advances in RM-1929 clinical development in recurrent head and neck cancer, including fast track designation granted by the FDA
16 January 2018 - Aspyrian plans to initiate pivotal clinical trials for RM-1929 in the first quarter of 2018. ...
Posted by Michael Wonder on 17 Jan 2018
An open letter to Dr. Scott Gottlieb on FDA transparency
17 January 2018 - Dear Dr. Scott Gottlieb: ...
Posted by Michael Wonder on 17 Jan 2018
Gottlieb changes course on FDA publication of rejection letters
16 January 2018 - Before Scott Gottlieb was in charge of the FDA, he called on the agency to publicly ...
Posted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 16 Jan 2018
Statement from FDA Commissioner in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
16 January 2018 - To encourage innovation and provide patients with access to the latest safe and effective medical technologies, we ...
Posted by Michael Wonder on 16 Jan 2018
Statement from FDA Commissioner responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
16 January 2018 - Today the U.S. Government Accountability Office published a report titled “Generic Drugs: FDA Should Make Public ...
Posted by Michael Wonder on 16 Jan 2018
Centrexion Therapeutics announces fast track designation granted by FDA to CNTX-4975 for treatment of knee osteoarthritis pain
16 January 2018 - Centrexion Therapeutics today announced that the U.S. FDA has granted fast track designation to CNTX-4975 for ...
Posted by Michael Wonder on 16 Jan 2018
FDA Commissioner on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
16 January 2018 - Scientific progress and new drug innovation don’t take place in a vacuum. ...