A look at the U.S. Food and Drug Administration’s drug approval review calendar.
The U.S. Food and Drug Administration approved Incyte’s Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test.
The U.S. Food and Drug Administration accepted a New Drug Application and two supplemental NDAs for Genentech’s Xofluza (baloxavir marboxil).
As pharma companies bolster their pipelines via multibillion-dollar acquisitions, drug manufacturers continue to heavily invest in the oncology space.
MedAdNews spoke to Bill Dreitlein, Senior Director, Pipeline & Drug Surveillance at OptumRx, about the state of the industry’s prescription drug pipeline and what enticing prospects will soon emerge.
Clarivate Analytics pegged 11 drugs set to enter the market during 2020 as potential blockbusters by 2024
Incyte Corporation’s pivotal Phase III GRAVITAS-301 trial of itacitinib in combination with corticosteroids in treatment-naïve acute graft-versus-host disease (GVHD) did not hit the primary endpoint, sending company shares down almost 10 percent.
Dublin, Ireland-based Alkermes is acquiring Boston-based Rodin Therapeutics for $100 million up front and up to $850 million in milestone payments.
Sanofi is pressing the U.S. Food and Drug Administration to keep the company’s patient experience data consistent following a review of approved applications required by the 21st Century Cures Act.
Gilead Sciences Inc. and Galapagos NV announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib – an investigational, oral, selective JAK1 inhibitor for the treatment of moderately to severely active rheumatoid arthritis (RA) – are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier during 2019.