The FDA has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) from AbbVie, an all-oral, interferon-free...
In consultation with the FDA, the US prescribing information for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and...
AbbVie’s New Drug Application (NDA) has been accepted by the FDA for a once-daily, fixed-dose formulation of the components of...
The FDA has approved a supplemental New Drug Application (sNDA) for the use of Viekira Pak (ombitasvir, paritaprevir, and ritonavir...
AbbVie has announced new data from its ongoing Phase IIIb TOPAZ-II study evaluating Viekira Pak (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir...
Phathom Pharmaceuticals, Inc. announced regulatory updates for its approved products, Voquezna Triple Pak and Voquezna Dual Pak, approved in the U.S. for the treatment of H. pylori infection, and its pending New Drug Application (NDA) for vonoprazan for the treatment of erosive esophagitis
Janssen Sciences has announced results for its Hepatitis C treatment Olysio plus Sovaldi (simeprevir plus sofosbuvir) in Genotype 1 HCV...
-Merck Inc., has notified the FDA that it will stop selling its Victrelis (boceprevir) treatment for Hepatitis C in the...
The FDA granted final approval of a New Drug Application for Kitabis Pak, from PulmoFlow, a co-packaging of generic tobramycin...
Merck has announced that the company has submitted a New Drug Application to the FDA for grazoprevir/elbasvir (100mg/50mg), an investigational...