5 December 2019 - The U.S. FDA has approved three applications for first generics of Gilenya (fingolimod) capsules for the ...
27 November 2019 - Hikma Pharmaceuticals today announces that it has submitted to the US FDA its response to deficiencies in ...
26 November 2019 - Deferred prosecution agreements among resolutions discussed. ...
19 November 2019 - Brand name makers’ patent action limits release of the lower-price medicines, hindering cost-control efforts. ...
16 October 2019 - On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals. ...
16 October 2019 - FDA generic drug approvals reach record high in fiscal year 2019. ...
14 October 2019 - Although the FDA has maintained that additional generic approvals should promote competition and alleviate shortages, the ...
11 October 2019 - Amid increasing abbreviated new drug application approvals, efforts by the US FDA to promote generic drug development ...
16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...
29 August 2019 - The U.S. Food and Drug Administration on Thursday granted Mylan tentative approval for its generic version ...
19 August 2019 - Sarepta Therapeutics today announced it had received a complete response letter from the U.S. FDA regarding ...
15 August 2019 - The US FDA on Wednesday released quarterly data on two of its programs aimed at increasing generic ...
7 August 2019 - Companies that make generic drugs—which have the same active ingredients as brand-name drugs—have to apply for ...
22 July 2019 - On July 19, the U.S. FDA approved multiple applications for first generics of Lyrica (pregabalin) for the ...
16 July 2019 - Republican Mike Kelly (R-PA) sent a letter Tuesday to US FDA Acting Commissioner Ned Sharpless questioning ...