Accomplished Medical Physicist will drive relevant activities related to Antibody Radiation Conjugates for targeted conditioning, therapeutic combinations, and AWE technology platform development Read More »

Approval based on statistically significant and clinically meaningful overall survival benefit demonstrated in the CELESTIAL phase 3 pivotal trial Read More »

BIOC51 Antimicrobial Activity against Bacillus anthracis (Anthrax), Adding to the List of Bacteria Susceptible to the Company's Drug Candidate Read More »

Safe Rx announced its product availability in AmerisourceBergen, with merchandising kits available to all AmerisourceBergen California customers. Read More »

Comprised of an experienced leadership team, visionary investors, and renowned scientists in cell therapy, gene therapy, and gene editing Read More »

SOPHiA GENETICS, a leading health tech company, announced the closing of a $77 million investment round to accelerate the democratization of Data-Driven Medicine. 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 »

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

Award Supports Advancement of BIOC51 Through Toxicology Studies in 2019 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 »

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 »

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

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

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 »

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 »

The U.S. Food and Drug Administration approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. Read More »

New grants support FDA’s GDUFA priorities of expanding bioequivalence methods for topical dermatological products and improving PBPK models of drug absorption via complex delivery routes Read More »

Arixa Pharmaceuticals issued the following announcement on Nov. 12.Arixa Pharmaceuticals™, Inc., a company dedicated to developing oral antibiotics for drug-resistant Gram-negative infections, today announced publication of a paper describing the chemistry of its oral prodrug of avibactam, a previously intravenous (IV)-only beta lactamase inhibitor (BLI). Read More »