Topic: complete response letter
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.
China issued expansive drug policy change guidelines, the FDA rejected Mylan and Biocon's Neulasta biosim, C-Bridge hired ex-GSK exec Hussain.
The FDA has issued Biocon and partner Mylan a complete response letter for their biosimilar of chemotherapy drug Neulasta tied to manufacturing.
Valeant says the situation is looking up at that Bausch + Lomb plant that has twice been responsible for Valeant receiving a CRL for a new eye drug.
The FDA has again turned down approval of a new eye drug from Valeant because of manufacturing issues at its Bausch + Lomb plant in Tampa, Florida.
Eli Lilly’s RA med baricitinib had been pegged as one of 2017’s hottest launches—and a threat to Pfizer’s Xeljanz. Not anymore.
Manufacturing has for the second time stepped on Ocular Therapeutix’s chance of an FDA approval for its new drug for pain following eye surgery.
Just a month after FDA staff gave a ringing endorsement to Pfizer's biosimilar for Amgen's blockbuster Epogen, the agency rejected the drug.
Merck's HPV shot Gardasil won approval in China, Lupin's Q4 sales in North America fell 13%, and China’s CANbridge gained a $25M series B.