Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in regards to its New Drug Application (NDA) for tadalafil oral film (OF). Read More »

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient Read More »

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Read More »

AbbVie (NYSE: ABBV) announced today patent license agreements with Pfizer over its proposed biosimilar adalimumab product. Read More »

Concordia International Corp. ("Concordia" or "the Company") (TSX: CXR), today announced that shareholders voted in favour of a special resolution authorizing the Company to amend its articles to change its name from Concordia International Corp. to ADVANZ PHARMA Corp. Read More »

Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Read More »

Fimbrion Therapeutics, Inc. announced that under its joint research collaboration with GSK, researchers have identified an orally available, small molecule development candidate for the treatment and prevention of urinary tract infections (UTIs). Read More »

Mylan achieves key milestone to provide U.S. diabetes patients with more affordable generic version of Sanofi's Lantus® insulin glargine vials Read More »

Award Supports Advancement of BIOC51 Through Toxicology Studies in 2019 Read More »

First and Only FDA-Approved Inhaled Levodopa for Intermittent Treatment of OFF Episodes in People with Parkinson’s Taking Carbidopa/Levodopa Read More »

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of a generic version of Elidel®1 (pimecrolimus) Cream, 1% in the U.S. Read More »