Blog
RSS FeedPosted by Michael Wonder on 02 Dec 2016
FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes
2 December 2016 - The U.S. FDA today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular ...
Posted by Michael Wonder on 02 Dec 2016
Arsanis receives FDA fast track designation for ASN100 for the prevention of Staphylococcus aureus pneumonia
1 December 2016 - Arsanis today announced that the U.S. FDA has granted fast track designation to ASN100 for the ...
Posted by Michael Wonder on 01 Dec 2016
Biosimilar therapy for ERBB2 (HER2)–positive breast cancer
1 December 2016 - Biologics is an umbrella term for therapeutic agents at least partially derived from living organisms such as ...
Posted by Michael Wonder on 01 Dec 2016
Scientific evidence and financial obligations to ensure access to biosimilars for cancer treatment
1 December 2016 - Articles in medical journals add to the scientific body of research that ultimately influences care. ...
Posted by Michael Wonder on 01 Dec 2016
U.S. FDA accepts for review a supplemental new drug application to expand labelling of Abilify Maintena (aripiprazole) for the treatment of bipolar I disorder
30 November 2016 - Application seeks to expand Abilify Maintena label to include maintenance treatment for bipolar I disorder. ...
Posted by Michael Wonder on 01 Dec 2016
FDA grants priority review to supplemental biologics license application for Merck’s Keytruda (pembrolizumab) in relapsed or refractory classical Hodgkin's lymphoma
1 December 2016 - Merck today announced that the U.S. FDA has accepted for review the supplemental biologics license application ...
Posted by Michael Wonder on 01 Dec 2016
House passes Health Bill to speed drug approvals, boost biomedical research
30 November 2016 - The $6.3 billion bill includes $1 billion to prevent and treat opioid addictions. ...
Posted by Michael Wonder on 01 Dec 2016
Emmaus Life Sciences receives notice of FDA PDUFA date for investigational L-glutamine treatment for sickle cell disease
29 November 2016 - Emmaus Life Sciences announced today that the U.S. FDA has set a PDUFA date of 7 ...
Posted by Michael Wonder on 30 Nov 2016
Drug approval by regulators: who watches the watchers?
30 November 2016 - In the latest issue of The Lancet Oncology, Ian Tannock and colleagues discuss some important parameters governing ...
Posted by Michael Wonder on 30 Nov 2016
F.D.A. agrees to new trials for ecstasy as relief for PTSD patients
29 November 2016 - After three tours in Iraq and Afghanistan, C. J. Hardin wound up hiding from the world ...
Posted by Michael Wonder on 30 Nov 2016
Ariad announces FDA full approval and label update for Iclusig (ponatinib) based on long-term efficacy and safety data from Phase 2 PACE clinical trial
29 November 2016 - Full approval granted through completion of accelerated approval commitments for rare cancer patients who may have ...
Posted by Michael Wonder on 29 Nov 2016
FDA accepts the biologics license application for avelumab for the treatment of metastatic Merkel cell carcinoma for priority review
29 November 2016 - Avelumab has previously received FDA breakthrough therapy and fast track designations for metastatic Merkel cell carcinoma, ...
Posted by Michael Wonder on 29 Nov 2016
Improving the accelerated pathway to cancer drug approvals
29 November 2016 - The US FDA must balance the need to bring potentially lifesaving drugs to market with the need ...
Posted by Michael Wonder on 29 Nov 2016
Cancer immunology community seeks better end points
29 November 2016 - Drug developers are still hunting for surrogate end points that can better capture the benefits of checkpoint ...
Posted by Michael Wonder on 29 Nov 2016
Amicus Therapeutics announces U.S. regulatory pathway for migalastat hydrochloride for Fabry disease
28 November 2016 - Regulatory plan for full approval pathway based on generation of additional gastro-intestinal symptoms data. ...