Blog
RSS FeedPosted by Michael Wonder on 23 Mar 2017
This is not a test: RMAT designation goes live
21 March 2017 - The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue ...
Posted by Michael Wonder on 22 Mar 2017
Duke experts caution against loosening FDA regulations
20 March 2017 - President Donald Trump has made cutting back on FDA regulations a priority, but what are the ...
Posted by Michael Wonder on 21 Mar 2017
Drug, device industries get one year delay on off label rule
20 March 2017 - The FDA is hitting the pause button on a recent rule affecting what drug and device ...
Posted by Michael Wonder on 21 Mar 2017
FDA approves drug to treat Parkinson’s disease
21 March 2017 - The U.S. FDA today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease ...
Posted by Michael Wonder on 21 Mar 2017
Humacyte receives FDA regenerative medicine advanced therapy expedited review designation for Humacyl in vascular access for haemodialysis
20 March 2017 - Humacyte announced today that the U.S. FDA has granted Humacyl, its investigational human acellular vessel, the ...
Posted by Michael Wonder on 20 Mar 2017
Array BioPharma provides update on FDA submission for binimetinib
20 March 2017 - NRAS mutant melanoma NDA withdrawn based on thorough discussions with FDA and following late cycle review meeting. ...
Posted by Michael Wonder on 20 Mar 2017
A better balance between accelerated access and high priced new drugs: a new conditional approval option
20 March 2017 - There are two different storms brewing in the pharmaceutical world. On the one hand there is ...
Posted by Michael Wonder on 20 Mar 2017
Four former FDA commissioners denounce drug importation, citing dangers to consumers
17 March 2017 - The four most recent FDA commissioners are warning Congress that legalising the importation of drugs from ...
Posted by Michael Wonder on 18 Mar 2017
Guide to recent biosimilar activity by FDA and in the Supreme Court
16 March 2017 - The US FDA recently completed a flurry of activity to help define the biosimilar pathway, including ...
Posted by Michael Wonder on 18 Mar 2017
AstraZeneca receives complete response letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia
17 March 2017 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 16 Mar 2017
Sunovion submits supplemental new drug application to FDA for use of Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children 4 years of age and older
15 March 2017 - If approved, Aptiom would provide an important new monotherapy or adjunctive therapy treatment option for individuals ...
Posted by Michael Wonder on 16 Mar 2017
GSK announces US regulatory submission seeking expanded indication for Fluarix Quadrivalent (influenza vaccine) for infants 6 months and older
15 March 2017 - GSK today announced the submission of a supplemental biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 16 Mar 2017
Marathon's $89,000 drug scrutinised for ‘unusual’ approval
16 March 2017 - Marathon Pharmaceuticals is under new scrutiny as Washington lawmakers press U.S. regulators about the “unusual circumstances” ...
Posted by Michael Wonder on 15 Mar 2017
FDA approves Merck’s Keytruda (pembrolizumab) for adult and paediatric patients with classical Hodgkin lymphoma refractory to treatment, or who have relapsed after three or more prior lines of therapy
14 March 2017 - Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat classical Hodgkin's lymphoma regardless of prior ...
Posted by Michael Wonder on 15 Mar 2017
Merck provides update on supplemental biologics license application for Keytruda (pembrolizumab) in previously treated advanced microsatellite instability-high cancer
14 March 2017 - Merck today announced that the U.S. FDA has extended the action date for the supplemental biologics ...