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RSS FeedPosted by Michael Wonder on 04 Jun 2019
Public disclosure of the filing of new drug and therapeutic biologics applications with the US Food and Drug Administration
3 June 2019 - Current regulations prohibit the US FDA from publicly disclosing the existence of pending new drug applications or ...
Posted by Michael Wonder on 04 Jun 2019
bluebird bio announces EU conditional marketing authorisation for Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia who do not have β0/β0 genotype
3 June 2019 - European marketing authorisation for Zynteglo follows the fastest assessment of an advanced therapy medicinal product as part ...
Posted by Michael Wonder on 04 Jun 2019
US FDA review for Scenesse extended by three months
3 June 2019 - The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision. ...
Posted by Michael Wonder on 04 Jun 2019
SpringWorks Therapeutics announces FDA fast track designation for PD-0325901 for the treatment of a severe form of neurofibromatosis type 1
3 June 2019 - SpringWorks Therapeutics today announced that the U.S. FDA has granted fast track designation for PD-0325901, an investigational, ...
Posted by Michael Wonder on 03 Jun 2019
FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia
3 June 2019 - The U.S. FDA today approved a new indication for the previously FDA approved drug, Zerbaxa (ceftolozane and ...
Posted 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
Pfenex and Alvogen announce European Medicines Agency accepts marketing authorisation application for PF708
30 May 2019 - Pfenex and Alvogen today announced that the EMA has accepted the marketing authorisation application submitted by our ...
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 ...