Four weeks after Germany pulled the manufacturing authorization for a Dr. Reddy’s plant in India, it has blocked a second one.
After issuing a warning letter to India’s Mahendra Chemicals, the agency has followed up by putting its API operation after finding a data and document…
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.
Hong Kong’s Department of Health started an investigation after a doctor was found giving expired FluQuadri vaccines to patients.
Sun's quarterly U.S. sales dropped 42%, BeiGene offers a public offering of $175 million and the FDA sent a Form 483 to Biocon.
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.
French drug regulators slapped Chinese API maker Chongqing Succeway Pharmaceutical with a warning letter and issued a recall following an inspection last month…
Gilead hit with revived lawsuit claiming it sourced a key HIV drug ingredient from an unapproved Chinese manufacturer.
Mylan and Biocon have hit a stumbling block that will delay potential approval of their biosimilar of Roche’s Herceptin in Europe.