Blog
RSS FeedPosted by Michael Wonder on 03 Jun 2019
FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer
3 June 2019 - Today, the U.S. FDA Oncology Center of Excellence announced a new pilot program to assist oncology health ...
Posted by Michael Wonder on 03 Jun 2019
Galt Pharmaceuticals answers the call for better practices in pain management with a non-opioid therapeutic alternative
29 May 2019 - Officials with the FDA have given priority review designation to an opioid-free pain management treatment from ...
Posted by Michael Wonder on 03 Jun 2019
Novartis shows growing strength in lung cancer innovation with new capmatinib investigational data
3 June 2019 - The U.S. FDA recently granted capmatinib breakthrough therapy designation for the treatment of patients with metastatic NSCLC ...
Posted by Michael Wonder on 01 Jun 2019
When ‘right to try’ isn’t enough: Congress wants a single ALS patient to get a therapy never tested in humans
31 May 2019 - A family in Iowa believes the FDA will decide whether their only surviving daughter lives or ...
Posted by Michael Wonder on 31 May 2019
U.S. FDA grants priority review for daratumumab in combination with bortezomib, thalidomide and dexamethasone in frontline multiple myeloma
30 May 2019 - 26 September 2019 PDUFA date. ...
Posted by Michael Wonder on 31 May 2019
Epizyme submits new drug application to the U.S. FDA for tazemetostat for the treatment of patients with epithelioid sarcoma
30 May 2019 - Submission follows productive pre-NDA meeting and marks on-time execution of first of two NDA submissions planned for ...
Posted by Michael Wonder on 31 May 2019
U.S. FDA approves supplemental new drug application adding overall survival data for Xospata (gilteritinib)
30 May 2019 - Phase 3 ADMIRAL trial showed patients treated with Xospate demonstrated longer overall survival than those who ...
Posted by Michael Wonder on 30 May 2019
Rockwell Medical announces submission of new drug application for I.V. Triferic
29 May 2019 - I.V. Triferic was developed through Special Protocol Assessment with FDA based on equivalence approach to Dialysate Triferic. ...
Posted by Michael Wonder on 30 May 2019
Mesoblast initiates rolling submission of biologics license application to U.S. FDA for remestemcel-L in the treatment of acute graft versus host disease
30 May 2019 - Mesoblast today announced that it has filed the first component of a rolling submission for a biologics ...
Posted by Michael Wonder on 30 May 2019
Fibrocell receives FDA regenerative medicine advanced therapy designation for FCX-007 gene therapy for the treatment of RDEB
29 May 2019 - Fibrocell Science today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 30 May 2019
Bayer receives U.S. FDA breakthrough therapy designation for copanlisib for the treatment of marginal zone lymphoma
29 May 2019 - Breakthrough therapy designation for copanlisib primarily based on follow-up data from the pivotal Phase II study ...
Posted by Michael Wonder on 30 May 2019
Zymeworks' lead asset, ZW25, granted fast track designation from the FDA
29 May 2019 - Zymeworks today announced that the U.S. FDA has granted fast track designation to ZW25, a novel azymetric ...
Posted by Michael Wonder on 30 May 2019
Arvinas receives fast track designation for its targeted protein degrader ARV-110 as a treatment for men with metastatic castration-resistant prostate cancer
29 May 2019 - Arvinas today announced that its lead Protac protein degrader, ARV-110, has been granted fast track designation by ...
Posted by Michael Wonder on 30 May 2019
Imara announces FDA fast track designation for IMR-687 for the treatment of sickle cell disease
29 May 2019 - Imara today announced that the U.S. FDA has granted fast track designation to IMR-687, the company’s ...
Posted by Michael Wonder on 29 May 2019
FDA officials call for patient-friendly terminology in oncology
29 May 2019 - Officials from the US FDA's oncology offices say they plan to develop a glossary of patient-friendly ...