Home » Topics » Regulatory

Regulatory
RSS

FDA first to approve Darzalex for multiple myeloma

Nov. 17, 2015

Two Baxalta hemophilia A products approved in Europe, U.S.

Nov. 16, 2015

FDA approves Tagrisso to treat certain patients with NSCLC

Nov. 16, 2015

FDA approves label expansion for Harvoni

Nov. 13, 2015

FDA approves Genvoya single-tablet regimen for HIV-1

Nov. 6, 2015

Health Canada approves Cingal for osteoarthritis knee pain

Nov. 5, 2015

FDA first to approve GlaxoSmithKline's Nucala

Nov. 5, 2015

FDA approves Imlygic as first oncolytic viral therapy in U.S.

Oct. 28, 2015

FDA approves Belbuca buccal film for chronic pain

Oct. 28, 2015

FDA approves Yondelis for liposarcoma and leiomyosarcoma

Oct. 26, 2015

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for June 16, 2025.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for June 16, 2025.
Zusduri flurry ends; ‘set up’ at ODAC, Urogen prevails with FDA
BioWorld
During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a...
23andme founder-led group outbids Regeneron for company
BioWorld
The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against...
Elevidys’ second liver death hits Sarepta, sends DMD ripples
BioWorld
How the U.S. FDA might respond became a serious question for Wall Street as Sarepta Therapeutics Inc. made known a second death due to acute liver failure with...