The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert.
The FDA has issued a scathing warning letter to a Pfizer unit that produced EpiPens that failed during emergencies, some of them fatal.
After patient deaths cropped up in multiple myeloma studies featuring Merck’s Keytruda, the FDA isn’t taking any chances with Opdivo.
Hospira issued a voluntary recall of one lot of hydromorphone and four lots of Levophed due to the potential of a lack of sterility.
Last month, following deaths in two Keytruda trials, the FDA halted the pair of Merck studies. And now, it’s warning the public about what’s at stake.
The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found.
A generics maker in the U.K. had its manufacturing certification pulled after regulators found data-reporting issues.
The FDA has classified the ongoing recall by drug wholesaler Truxton of 18 lots of phenobarbital and amitriptyline tablets as Class I and Class II recalls.…
The FDA slapped Foshan Flying Medical with a warning letter for inadequate testing, validation and training issues at its plant in Guangdong, China.
The FDA bit into homeopathic pharmaceutical manufacturer Homeolab USA over belladonna-treated teething products that CVS took off the shelf last year.