Topic: FDA warning letter
Shionogi’s flu drug won Japanese approval; Sun Pharma's Halol plant was cited by the FDA; EpimAb hired a top Novartis researcher as CMO; plus more.
An Indian drugmaker has halted production of a couple of APIs after FDA inspectors found it was falsifying data at its manufacturing complex near Tamil Nadu, India.
The FDA's ad police have sent Collegium Pharmaceuticals their first letter of the year. And it tackles a hot-topic category: opioids.
After a year of remediation, an Indian drugmaker has worked its way out from under an FDA warning letter issued for its sterile injectables operation.
A recently released FDA document shows that Pfizer's troubled fill-finish plant in Kansas was cited for continuing to repeat mistakes already cited by the FDA.
The FDA has issued a warning letter to a Bayer finished products plant in Germany, where it says poor cleaning led to product cross-contamination.
The impact of an FDA warning letter issued last month for a Celltrion plant in South Korea has broadened to Teva Pharmaceuticals.
Teva just went through a horrible year, today reporting a $17.5 billion operating loss in 2017, but execs said things will get worse before they get better.
Mylan and Biocon win CHMP nod for a Lantus biosimilar, Takeda's Zika vaccine fast-tracked by the FDA, Celltrion got a warning letter.
The FDA has issued a warning letter for the Celltrion plant in South Korea that makes Pfizer's Remicade biosimilar, Inflectra.