Topic: complete response letter
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.
Novartis’ prospects for launching a copy of GlaxoSmithKline’s Advair this year just went from highly unlikely to not happening.
CEO Vas Narasimhan has said Novartis' Advair generic—specifically its approval this year—was one of his top three worries. That worry just grew.
Valeant has overcome manufacturing problems at a Bausch & Lomb plant to win approval of its long-delayed eye drug.