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RSS FeedPosted by Michael Wonder on 17 Jun 2017
Adamis wins U.S. approval to sell EpiPen rival, shares soar
15 June 2017 - Adamis Pharmaceuticals said on Thursday it received U.S. approval for its emergency epinephrine syringes to treat ...
Posted by Michael Wonder on 15 Jun 2017
FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus
15 June 2017 - Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference ...
Posted by Michael Wonder on 10 Jun 2017
FDA approves first generic of drug for prevention of HIV and to treat HIV-1
9 June 2017 - On 8 June 2017, the U.S. FDA approved the first generic version of Truvada for the ...
Posted by Michael Wonder on 31 May 2017
ProQR receives fast track designation from the FDA for QR-110 for Leber’s congenital amaurosis type 10
31 May 2017 - QR-110 is currently in clinical development with the planned Phase 1/2 open-label trial (PQ-110-001) that will assess ...
Posted by Michael Wonder on 30 May 2017
FDA approves first generic Strattera for the treatment of ADHD
30 May 2017 - The U.S. FDA today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder ...
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 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 03 Mar 2017
A citizen’s pathway gone astray — delaying competition from generic drugs
1 March 2017 - Many medicines are making headlines these days not for their breathtaking ability to save lives, but for ...
Posted by Michael Wonder on 27 Feb 2017
2016: A record-setting year for generic drugs
24 February 2017 - Over the last 10 years, generic drugs have saved the U.S. health care system about $1.68 trillion. ...
Posted by Michael Wonder on 03 Feb 2017
U.S. House panel to take up bill to spur generic drug development
2 February 2017 - A U.S. House of Representatives subcommittee will take up bipartisan legislation next week to foster generic ...
Posted by Michael Wonder on 18 Jan 2017
FDA approves a generic of Xyrem with a REMS Program
17 January 2017 - The U.S. FDA has approved the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat ...
Posted by Michael Wonder on 19 Dec 2016
20 states accuse generic drug companies of price fixing
15 December 2016 - A wide-ranging investigation into generic drug prices took its most significant turn yet on Thursday, as ...
Posted by Michael Wonder on 14 Dec 2016
Two executives charged in generic drug price-fixing federal investigation
14 December 2016 - The U.S. filed its first charges in a generic drug price-fixing probe on Wednesday. ...
Posted by Michael Wonder on 09 Dec 2016
Cipla receives final FDA approval for generic Baraclude tablets
8 December 2016 - Cipla has received final approval for its abbreviated new drug application for entecavir 0.5 mg and ...
Posted by Michael Wonder on 02 Nov 2016
Generic drug backlog at the FDA: a dive into the confusing numbers
2 November 2016 - As the debate over skyrocketing drug prices continues, at least one solution has cropped up in ...