We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.

I Agree

You are here: Industry Insights > rejection

News List

10 years after a rejection, Merck returns to the FDA with a Gardasil 9 age expansion bid fiercevaccines
July 23, 2018
How long is a drugmaker willing to wait on an indication expansion plan? For Merck’s HPV vaccines, that's 10 years.
10 years after a rejection, Merck returns to the FDA with a Gardasil 9 age expansion bid fiercevaccines
June 26, 2018
How long is a drugmaker willing to wait on an indication expansion plan? For Merck’s HPV vaccines, that's 10 years.
Sandoz US woes continue with biosimilar rejection pharmafile
May 04, 2018
In Novartis’ recently released Q1 results, which largely beat analysts’ estimates, Sandoz was a black spot on its record – with sales of the generics unit down by 18%.