Drug Rescue
Innovation Worth Watching: How Ignota Labs Leverages AI to Rescue Promising but Failing Drugs
David Alvaro, Ph.D.
Pharma's Almanac
PAO-08-25-NI-06Aug 06, 2025
Regulatory
FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review
U.S. Food & Drug Administration
PR-M03-22-03Mar 07, 2022
Improving the Handling and Safety of Pharmaceutical Raw Materials Through Dry Granulation
Thomas Briel, Ph.D.; Moritz Beck-Broichsitter, Ph.D.
MilliporeSigma
PA141Jan 28, 2022
Process Development
Designing More Sustainable Small Molecule API Manufacturing Processes
Marko Salo; Arne Grumann
Fermion
PAO-09-21-CL-05Sep 16, 2021
Fecal Transplant
Fecal Transplant Associated with One Patient Death
Pharma's Almanac
PAO-M06-19-NI-020Jun 21, 2019
FDA Action
FDA Orders Manufacturers of Surgical Mesh Intended for Transvaginal Repair of Pelvic Organ Prolapse to Stop Selling All Devices
U.S. Food & Drug Administration
PR-M04-19-NI-060Apr 18, 2019
Safety Labeling
FDA Orders Important Safety Labeling Changes for Addyi
U.S. Food & Drug Administration
PR-M04-19-NI-045Apr 15, 2019
Public Health
FDA and CBP Bolster Collaboration to Protect Public Health and Safety
U.S. Food & Drug Administration
PR-M04-19-NI-034Apr 10, 2019
FDA
Statement from FDA on the Agency's List of Known Nitrosamine-free Valsartan and ARB Class Medicines
U.S. Food & Drug Administration
PR-M04-19-NI-035Apr 10, 2019
Stem Cells
Statement by FDA on Efforts to Stop Stem Cell Clinics and Manufacturers from Marketing Unapproved Products and Advance Legitimate Development
U.S. Food & Drug Administration
PR-M04-19-NI-031Apr 09, 2019
Drug Safety
BioIVT Launches Its XPRESSWAY® Profile Safety Package, a Gene Expression Reference Guide Designed to Improve Drug Safety Analyses
BioIVT
PR-M03-19-NI-024Mar 08, 2019
Quality Metrics
FDA Makes More Quality Moves
Nigel Walker
Nice Insight
PAO-M08-18-NI-006Jul 31, 2018