Keyword: Herceptin

Opdivo is the first I-O drug approved in China; Dr. Reddy's faces Suboxone Film patent spat; former multinational pharma executives jump to Chinese startups.

Puma's former senior director of regulatory affairs made more than $1 million by trading on nonpublic information, authorities say.

Celltrion says its biosimilars for Herceptin and Rituxan could be approved this year after it made plant improvements to resolve and FDA warning letter.

Experts say China's data sharing rule may hinder drug R&D; FDA rejects Mylan and Biocon's Lantus biosim and more news.

When Roche got Herceptin onto China’s insurance list, it didn’t expect demand to surge so fast. Now, it's shifting to a new plant to boost supplies.

Amgen and partner Allergan have become the latest to have the FDA issue a complete response letter for their version of Roche's Herceptin.

Celltrion says it has made enough progress fixing issues at its plant cited by the FDA and has resubmitted its application for its version of Rituxan.

Roche's Rituxan just got another break. Novartis says its knockoff version didn't pass muster at the FDA, likely lifting the U.S. biosim threat until 2019.

Pfizer stumbled at the FDA with its biosimilar application for a product that would challenge Roche's breast cancer stalwart Herceptin.