Reviewing FDA Warning Letters: July 2025 Edition
By Stephanie Vine
July 17, 2025
Poor aseptic practices, peeling paint, and unapproved opioids… I look at recent FDA warning letters.
3 min read
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Regulation & Standards
FDA Publishes Complete Response Letters
July 11, 2025
In an effort to increase transparency, the FDA has published letters sent to drug manufacturers after failing to secure approval
2 min read
This Week’s Biopharma News: FDA Urged to Back Abortion Pill Mifepristone
July 8, 2025
Our latest news roundup reports on a malaria medicine for babies, EMA plasma manufacturing recommendations, nanomedicine for bladder cancer treatment, and more
4 min read
This Week’s CGT News: CRISPR/Cas9 improves ASOs efficacy, and more
July 2, 2025
Our latest news roundup reports on how CRISPR/Cas9 improves ASOs efficacy, Abbvie’s latest acquisition, further sickle cell disease research, and more
3 min read
The Biosimulation Generation
July 1, 2025
Since the FDA announced plans to phase out mandatory animal testing, in silico drug discovery and development platforms are emerging. Welcome to the age of biosimulation.
6 min read
This Week’s Industry News, RFK Jr. criticizes Gavi, Trump Pulls Federal Subscriptions, and More
July 1, 2025
Our latest news roundup reports on thimerosal elimination, subscription termination, depression alleviation, and more
4 min read
This Week’s Biopharma News: Bayer, GSK, Eli Lilly, Novo Nordisk, and AZ – all positive.
June 26, 2025
Our latest news roundup reports on the Bayer-Tsinghua partnership expansion, GLP-1 diabetes treatments, and GSK EU acceptance of linerixibat.
3 min read
This Week’s Biopharma News: RFK Jr Selects New Members for US Vaccine Committee
June 19, 2025
Our latest news roundup reports on a new RSV FDA approval for Moderna, payment hikes in the UK, and calls in the US for a ban on direct-to-consumer advertising.
4 min read
Gene Therapy Successes in Ophthalmology
By Daniel Eisenman, James Riddle
June 18, 2025
Ophthalmology is quietly becoming gene therapy’s next big frontier. Here’s how the science, the patients, and the regulations are aligning.
8 min read
FDA Plans for Shorter Drug Reviews
By Kerri Miller
June 13, 2025
Martin A. Makary and Vinay Prasad write that “rapid or instant reviews” could be possible at the FDA.
3 min read
