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February 29, 2016
The program is intended to provide support to ongoing efforts in rare disease product development.
February 18, 2016
The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.
February 08, 2016
Stephen Ostroff published a blog on FDA regarding goals to modernize the generic drug review process in an effort to increase patient access to generics.
FDA officials said on Feb. 5, 2016 that Celltrion’s biosimilar to infliximab was “highly similar” to Johnson & Johnson’s (J&J) Remicade, according to a report by Reuters.
February 02, 2016
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
January 28, 2016
The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.
Amgen announces FDA will review the company’s BLA for ABP 501.
On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.
January 15, 2016
The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.
January 07, 2016
FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.