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.
Mylan and Biocon have won an EU recommendation for their Lantus biosimilar after overcoming manufacturing concerns that forced a delay last summer.
U.S biotech Evolus alerted investors that FDA concerns with a Daewoong plant in South Korea that will make its Botox copy could delay its approval.
A Sanofi executive said the company will "shoulder the cost" of any adverse events that are scientifically linked to vaccination.
As investigations in the Philippines proceed, Sanofi Pasteur has agreed to refund the cost of unused Dengvaxia doses worth about $28 million.
The EMA has decided to block the API for amoxicillin trihydrate produced by a company in China whose manufacturing oversight has been lacking.