Topic: FDA warning letter
Astellas tapped Adaptimmune to develop T-cell therapies. Ireland hit Takeda with an unexpected Shire tax bill. PD-1 med Tyvyt hit its goal in NSCLC.
A Chinese OTC drugmaker gets the distinction of ringing in the new year as the first company to be slapped with an FDA warning letter.
The FDA's ad watchdog served its most serious violation to Alkermes Wednesday—and it took the unusual step of announcing that violation to the world.
The FDA has come down on a small U.S. drugmaker for taking a skin medication to market even though there were out-of-spec test results at release.
The FDA has slapped a U.S. drug repackager, saying in a warning letter that its storage processes and equipment cleaning are not up to expectations.
The FDA's ad watchdog, the Office of Prescription Drug Promotion, sent untitled letters to Nascent Biotech and Rockwell Medical in November.
Novartis pivots Shanghai R&D from discovery to development. BeiGene nabs FDA nod for BTK inhibitor Brukinsa. FDA clears Shionogi's antibiotic Fetroja.
The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.
The cleaning procedures are so poor at a Zydus Cadila plant in India that the FDA says a sampling found 10 different cross-contaminated products.
Mylan is the most recent drugmaker facing the FDA's ire over a tainted API that led to a global recall of "sartan"-based drugs last year.