How Firm Is the iPLEDGE REMS? Assessing the Near-Term Outlook
The FDA’s iPLEDGE REMS is designed to curb embryo‑fetal risk. What is actually known about its status—and how likely is formal confirmation in the coming week?
Tag • 5 articles
Pharma & FDA
Articles currently tagged Pharma & FDA.
Torrent Pharmaceuticals Cited by FDA for Adulterated Finished Drugs
U.S. regulators have flagged Torrent Pharmaceuticals Limited for CGMP violations tied to adulterated finished medicines, raising quality and oversight questions.
Why Trump’s MAHA Base Is Restless Over Undelivered Pharma Crackdowns
A new POLITICO poll shows strong public appetite to confront big drug makers—yet Trump’s actions so far fall short of what many MAHA supporters expected.
How Every Cure’s Drug Search Aims to Rewrite Rare Disease Treatment
A small nonprofit is trying to match existing drugs to overlooked rare diseases, challenging how new treatments are usually found and funded.
FDA clears rare disease drug as Washington scrutiny on patents intensifies
A new FDA approval for a rare genetic disorder lands as senators press patent officials and lawmakers push to cap insulin costs.