A 200-patient Phase II pilot study has begun to examine the efficacy and safety of the Shok-Pak, from InflammaGen Therapeutics,...
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
The FDA has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) from AbbVie, an all-oral, interferon-free...
The FDA granted final approval of a New Drug Application for Kitabis Pak, from PulmoFlow, a co-packaging of generic tobramycin...
The FDA has added more data to the indication of Kyprolis with dexamethasone �specifically, data that showed Kyprolis from Amgen,,...
AbbVie’s New Drug Application (NDA) has been accepted by the FDA for a once-daily, fixed-dose formulation of the components of...
Purpose: Oral melphalan and dexamethasone (MDex) were considered a standard of care in light-chain (AL) amyloidosis. In the past decade, bortezomib has been increasingly used in combination with alkylating agents and dexamethasone. We prospectively compared the efficacy and safety of MDex and MDex with the addition of bortezomib (BMDex).
In consultation with the FDA, the US prescribing information for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and...
The National Institute for Health and Care Excellence (NICE) in a final appraisal now recommends Farydak + Velcade (panobinostat +...