Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2017
Braeburn and Camurus announce submission for CAM2038 for opioid use disorder
20 July 2017 - Priority review of the NDA has been applied for which, if granted, would shorten the review process ...
Posted by Michael Wonder on 20 Jul 2017
Keeping the U.S. prescription drug supply chain among the safest in the world
20 July 2017 - The U.S. prescription drug supply is among the safest in the world, but it can be challenging ...
Posted by Michael Wonder on 20 Jul 2017
Merck announces U.S. FDA grants tentative approval for Lusduna Nexvue (insulin glargine injection), a follow-on biologic basal insulin
20 July 2017 - Merck today announced that the U.S. FDA has granted tentative approval for Lusduna Nexvue™ (insulin glargine ...
Posted by Michael Wonder on 19 Jul 2017
Capricor receives rare paediatric disease designation from FDA for CAP-1002 for patients with Duchenne muscular dystrophy
18 July 2017 - Designation covers broad treatment of Duchenne muscular dystrophy. ...
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 17 Jul 2017
Building a strong FDA workforce to bring scientific advances to patients
17 July 2017 - The key to FDA’s public health mission, and its ability to bring innovative new therapies to patients, ...
Posted by Michael Wonder on 17 Jul 2017
FDA approves new treatment to reduce the risk of breast cancer returning
17 July 2017 - The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, ...
Posted by Michael Wonder on 17 Jul 2017
Amgen and UCB provide update on regulatory status of Evenity (romosozumab) in the US
16 July 2017 - Amgen and UCB today announced that the U.S. FDA has issued a complete response letter for ...
Posted by Michael Wonder on 17 Jul 2017
Amgen submits regulatory applications in US and Europe to include overall survival data in Kyprolis (carfilzomib) label
14 July 2017 - Data showed Kyprolis and dexamethasone reduced the risk of death by 21% and increased overall survival ...
Posted by Michael Wonder on 14 Jul 2017
FDA grants fast track designation to VT-1598 for treatment of Valley fever
13 July 2017 - Viamet Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to VT-1598, a ...
Posted by Michael Wonder on 14 Jul 2017
Janssen announces U.S. FDA approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis
13 July 2017 - Tremfya is the first and only biologic approved that selectively blocks interleukin 23. ...
Posted by Michael Wonder on 13 Jul 2017
Amgen and Allergan to discuss data supporting biologics license application for ABP 215, a biosimilar candidate to Avastin (bevacizumab)
13 July 2017 - First Amgen and Allergan oncology biosimilar candidate to be reviewed by U.S. FDA Advisory Committee ...
Posted by Michael Wonder on 13 Jul 2017
House poised to pass bill critical for drug industry; the Senate may be a slog
12 July 2017 - The House of Representatives is fast-tracking a vote on a key priority for the pharmaceutical industry, ...
Posted by Michael Wonder on 13 Jul 2017
Multidimensional evidence generation and FDA regulatory decision making defining and using “real-world” data
13 July 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making. ...
Posted by Michael Wonder on 12 Jul 2017
Ocular Therapeutix receives complete response letter from FDA for Dextenza NDA
11 July 2017 - No efficacy or safety issues raised by FDA. ...