Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 16 Jan 2018
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
16 January 2018 - The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab matches the reference ...
Posted by Michael Wonder on 16 Jan 2018
Teva announces U.S. FDA approval of Trisenox (arsenic trioxide) injection for first-line treatment of acute promyelocytic leukaemia
15 January 2018 - Teva Pharmaceutical Industries announced that the U.S. FDA has approved the use of Trisenox (arsenic trioxide) injection ...
Posted by Michael Wonder on 14 Jan 2018
Can your hip replacement kill you?
13 January 2018 - When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an ...
Posted by Michael Wonder on 13 Jan 2018
Cour Pharmaceuticals receives FDA fast track designation for TIMP-GLIA
8 January 2018 - TIMP-GLIA is designed to enable patients to develop tolerance to gluten. ...
Posted by Michael Wonder on 13 Jan 2018
FDA grants fast track designation to Concert Pharmaceuticals' CTP-543 for the treatment of alopecia areata
12 January 2018 - CTP-543 is a novel JAK inhibitor in Phase 2 for alopecia areata as potential first-in-class treatment. ...
Posted by Michael Wonder on 13 Jan 2018
GSK receives FDA approval for expanded indication for Fluarix Quadrivalent (influenza vaccine) for persons 6 months and older
11 January 2018 - GSK announced today it has received approval from the US FDA's Center for Biologics Evaluation and Research ...
Posted by Michael Wonder on 13 Jan 2018
Statement from FDA Commissioner on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
12 January 2018 - The FDA is committed to ensuring that we have the right policies and processes in place ...