Home » Topics » Regulatory

Regulatory
RSS

FDA approves Otiprio for pediatric patients undergoing tympanostomy tube placement

Dec. 14, 2015

FDA approves Vistogard to treat overdose or severe toxicities due to 5-FU or capecitabine

Dec. 14, 2015

Biocad's biosimilar bevacizumab approved in Russia

Dec. 11, 2015

Mexico approves Dengvaxia, world's first dengue vaccine

Dec. 10, 2015

Baxalta's Vonvendi is first FDA-approved recombinant von Willebrand factor

Dec. 9, 2015

Samsung Bioepis obtains Korean approval for Renflexis and updates pipeline status

Dec. 7, 2015

FDA approves Empliciti for previously treated multiple myeloma

Dec. 1, 2015

FDA approves Portrazza for metastatic squamous NSCLC

Nov. 25, 2015

FDA approves Opdivo for renal cell carcinoma

Nov. 24, 2015

Oxaliplatin and capecitabine regimen approved for gastric cancer adjuvant therapy in Japan

Nov. 23, 2015

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for July 16, 2025.
Today's news in brief
BioWorld MedTech
BioWorld MedTech briefs for July 16, 2025.
Atai Therapeutics discovers new 5-HT2A receptor partial agonists
BioWorld Science
Atai Therapeutics Inc. has synthesized new tetrahydro pyridine-substituted indole and azaindoles acting as 5-HT2A receptor partial agonists reported to be useful...
PHD inhibitors reported in Akebia Therapeutics patent
BioWorld Science
Akebia Therapeutics Inc. has identified new derivatives of ([1,2,4]triazolo[5,1-a]isoquinoline-5-carbonyl)glycinate acting as prolyl 4-hydroxylase (PHD) inhibitors.
FDA wants more data for Otsuka’s sNDA in PTSD
BioWorld
The U.S. FDA is insisting that another study is needed to bolster the sNDA for Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. in treating adults with...