Topic: FDA warning letter
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.
An API maker in Bizen, Japan, has joined a growing list of Japanese drugmakers to be criticized by the FDA in warning letters and bans.
Pfizer reported earnings today, including good news for Sandoz and partner Momenta.
Here's some of the other news we're following today.
An Indian company that has had its drugs banned by the FDA has bought a contract manufacturing operation in the U.S.
The FDA has nailed an Australian contract manufacturer with a warning letter for serious manufacturing and quality lapses.
From the FDA’s point of view, OTC drugs and weedkiller just don’t mix. That is the message delivered in a newly posted warning letter to an Iowa company.
Five months after blocking the products of Prosana Distribuciones from the U.S., the FDA has issued a warning letter for the Mexican company.
A Fresenius Kabi cancer drug plant savaged by the FDA in the past for hiding serious drug testing issues has been slapped with a new warning letter.