Shionogi's Roche-partnered Xofluza, a one-time, single-dose regimen, probably won't win U.S. approval till next winter.

Biocon and Mylan have hit another manufacturing snag on their march toward an FDA nod for their copy of Sanofi's blockbuster Lantus.  

After two refusals from Sanofi to provide a refund for the Dengvaxia program, officials in the Philippines say they are getting ready to sue.

After a year of remediation, an Indian drugmaker has worked its way out from under an FDA warning letter issued for its sterile injectables operation.

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.

The Philippine DOH is now officially asking Sanofi to refund some $39 million for used Dengvaxia doses as well.

Ready to challenge GlaxoSmithKline and Merck, India's Bharat Biotech has won WHO prequalification for its rotavirus vaccine Rotavac.

The WHO stopped classifying Zika as an emergency in late 2016, but Takeda has pressed ahead with its program, winning an FDA fast-track designation.