FDA releases its latest batch of Warning Letters that cite DSE Healthcare Solutions, Northwestern University and Opto-Pharm Pte Ltd.
Federal Register notice: FDA requests public comments on a new information collection related to a proposed Experimental Study on Warning Statements f...
The 3rd Circuit Appeals Court sends hundreds of plaintiffs claims against Mercks Fosamax back to a district court because the claims are not preempted...
FDA denies a 10/2016 Sandoz citizen petition that asked FDA not to approve generic copies of GlaxoSmithKlines asthma inhaler Advair Diskus 100/50 (flu...
FDA Webview editor Jim Dickinson analyzes what is known about the Trump budget proposals intentions for FDA and says they risk the collapse of the age...
FDA approves a Tesaro, Inc. NDA for Zejula (niraparib) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tu...
An Eagle Pharmaceuticals 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke has been accepted for priority review.
Allergan says it will file an NDA in the second half of this year after announcing data from two Phase 3 trials of sarecycline for treating moderate t...