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RSS FeedPosted by Michael Wonder on 01 Apr 2017
Akari Therapeutics announces FDA fast track designation for Coversin
30 March 2017 - Akari Therapeutics announced today that the US FDA has granted fast track designation for Coversin for treatment ...
Posted by Michael Wonder on 31 Mar 2017
Novo Nordisk resubmits new drug application for fast-acting insulin aspart in the US
29 March 2017 - Novo Nordisk today announced that the company has resubmitted the new drug application for fast-acting insulin ...
Posted by Michael Wonder on 31 Mar 2017
Tagrisso (osimertinib) receives US FDA full approval
31 March 2017 - Approval based on Phase III AURA3 trial that demonstrated significant improvement in progression-free survival with Tagrisso as ...
Posted by Michael Wonder on 31 Mar 2017
FDA approves expanded indication for Qudexy XR (topiramate) extended release capsules to include prophylaxis of migraine headache in adults and adolescents
30 March 2017 - Molecule most prescribed by neurologists for migraine prophylaxis now available in a unique 24 hour formulation. ...
Posted by Michael Wonder on 30 Mar 2017
FDA: helping small businesses get big results
30 March 2017 - It is well known that small business is vital to the success of the American economy. Less ...
Posted by Michael Wonder on 30 Mar 2017
U.S. FDA approves addition of moderate to severe fingernail psoriasis data to AbbVie's Humira (adalimumab) prescribing information
30 March 2017 - Phase 3 data demonstrate improvement in moderate to severe fingernail psoriasis. ...
Posted by Michael Wonder on 30 Mar 2017
Trump FDA nominee wants lower drug costs with more generics
29 March 2017 - Copycats for complex medicines like EpiPen to be top priority. ...
Posted by Michael Wonder on 30 Mar 2017
FDA grants priority review for Amgen's Blincyto (blinatumomab) supplemental biologics license application
29 March 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to ...
Posted by Michael Wonder on 30 Mar 2017
FDA officials: priority review drugs have higher likelihood of getting boxed warning after approval
29 March 2017 - A team of officials from the US FDA say that drugs approved following a priority review ...
Posted by Michael Wonder on 30 Mar 2017
Trump is slashing FDA rules. Why isn’t big pharma excited?
28 March 2017 - President Donald Trump is planning to take the ax to FDA regulations. ...
Posted by Michael Wonder on 30 Mar 2017
An FDA Commissioner for the 21st century
29 March 2017 - President Donald Trump has named Scott Gottlieb as his nominee to be the next commissioner of the ...
Posted by Michael Wonder on 30 Mar 2017
Scott Gottlieb and the credibility of U.S. therapeutics
29 March 2017 - President Donald Trump has nominated Scott Gottlieb as U.S. Commissioner of Food and Drugs. ...
Posted by Michael Wonder on 29 Mar 2017
Trump’s nominee to lead the FDA got paid millions by the health care industry
29 March 2017 - Dr. Scott Gottlieb, President Donald Trump's nominee to head the FDA, is a widely respected physician ...
Posted by Michael Wonder on 29 Mar 2017
Mylan comments on generic Advair Diskus abbreviated new drug application
29 March 2017 - Mylan today commented on the status of its abbreviated new drug application with the U.S. FDA ...
Posted by Michael Wonder on 29 Mar 2017
Regeneron's new drug price could disappoint everyone. Here's why that's a good thing.
28 March 2017 - It was a symbolic act that spoke volumes. ...