The FDA has again turned down approval of a new eye drug from Valeant because of manufacturing issues at its Bausch + Lomb plant in Tampa, Florida.

The Biocon sterile manufacturing plant that got spanked by European and FDA regulators earlier this year has taken another whipping by the FDA.

Dr. Reddy's CEO GV Prasad says the generic drugmaker’s top priority is to do what is needed to get its manufacturing up to FDA expectations.

The FDA has slapped an Italian sterile manufacturer with a warning letter pointing to the contamination hazards tied to its highly manual processes.

Baxter Pharmaceutical is voluntarily recalling sodium chloride dextrose units due to a lack of assurance of sterility and the possibility of leakage.

The EPA fined Maryland pharmaceutical manufacturer Jubilant Cadista $35,000 for violating several federal regulations regarding the storage of hazardous waste…

Manufacturing has for the second time stepped on Ocular Therapeutix’s chance of an FDA approval for its new drug for pain following eye surgery.

The FDA has issued a warning letter to India's Vista Pharmaceuticals after it found it using corroded equipment.

Mylan and Biocon have hit a stumbling block that will delay potential approval of their biosimilar of Roche’s Herceptin in Europe.

Regulatory