Topic: FDA warning letter
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.
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.