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RSS FeedPosted 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
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. ...
Posted by Michael Wonder on 29 Mar 2017
FDA approves Roche’s Ocrevus (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis
29 March 2017 - First and only approved disease-modifying therapy for primary progressive form of multiple sclerosis – one of the ...
Posted by Michael Wonder on 29 Mar 2017
Drop in US drug approvals but no similar trend in the EU
28 March 2017 - NDA Group announced findings from their fourth annual comparison of drug approvals in Europe and the ...
Posted by Michael Wonder on 29 Mar 2017
AstraZeneca shares progress on Lynparza (olaparib) tablets in the US
28 March 2017 - FDA grants priority review for maintenance setting in ovarian cancer patients with PDUFA set for Q3 ...
Posted by Michael Wonder on 28 Mar 2017
Tesaro won’t reveal price of ovarian cancer drug. But it’ll likely be near $14,000 a month.
28 March 2017 - Zejula’s main rivals cost around $13,700 and $12,600 a month, but Tesaro might be able to justify ...
Posted by Michael Wonder on 28 Mar 2017
Severe eczema drug is approved by FDA; price tag is $37,000 a year
28 March 2017 - The FDA on Tuesday approved a drug to treat people with a serious form of eczema, ...
Posted by Michael Wonder on 28 Mar 2017
FDA approves new eczema drug Dupixent
28 March 2017 - The U.S. FDA today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent ...