FDA postpones an 11/18 joint advisory committee that was going to vote on a Laboratoire HRA Pharma supplemental NDA for Opill (norgestrel, 0.075 mg), ...
FDA accepts for priority review a Seres Therapeutics BLA for its investigational oral microbiome therapeutic SER-109 for preventing recurrent C. diffi...
Federal Register notice: FDA announces an 11/17 public workshop entitled Quantitative Brain Amyloid PET Imaging in Patients with Alzheimers Disease....
The International Council for Harmonization posts a presentation outlining its finalized guidance entitled A Selective Approach to Safety Data Collect...
AstraZeneca reports positive results from two trials evaluating new breast cancer treatments.
Federal Register notice: FDA launches a Rare Disease Endpoint Advancement Pilot Meeting Program.
Federal Register notice: FDA makes available a draft guidance entitled In Vitro Permeation Test Studies for Topical Products Submitted in ANDAs.
Federal Register notice: FDA makes available a draft guidance entitled Physicochemical and Structural (Q3) Characterization of Topical Drug Products i...
