Topic: complete response letter
Only days after the FDA turned away Regeneron's Eylea for a label expansion, the drugmaker has secured the approval it sought.
The FDA has issued a CRL for Regeneron's application to extend the dosing schedule for blockbuster Eylea from eight to 12 weeks.
Portola has hired a 30-year pharma veteran to oversee its manufacturing after running into production delays for its blood thinner antidote.
Celltrion says its biosimilars for Herceptin and Rituxan could be approved this year after it made plant improvements to resolve and FDA warning letter.
Thought Mylan might snag a generic Advair approval on its second try? Think again.
Experts say China's data sharing rule may hinder drug R&D; FDA rejects Mylan and Biocon's Lantus biosim and more news.
The FDA has issued a complete response letter to partners Biocon and Mylan for their version of Sanofi’s blockbuster Lantus insulin.
Amgen and partner Allergan have become the latest to have the FDA issue a complete response letter for their version of Roche's Herceptin.
In a new twist on the good news/bad news paradigm, the FDA has informed Perrigo to expect a CRL for its copy of Teva’s popular ProAir inhaler.
Portola has won FDA approval of Andexxa, its antidote for some next-gen bloodthinners, but a manufacturing upgrade will limit initial supplies.