[ Price : $8.95]
FDA asks antimicrobial drug manufacturers to revise their labels under a voluntary plan to help phase out human-use antibiotics in...[ Price : $8.95]
FDA asks for labeling changes in all OTC topical antiseptic drug products indicated for preoperative or pre-injection skin prepara...[ Price : $8.95]
FDA approves a six-month priority review for Genzymes NDA for Cerdelga to treat adult patients with Gaucher Disease Type 1.[ Price : $8.95]
CSL Behring tells FDA it opposes a citizen petition asking the agency to impose new safety measures on Berinert and Cinryze.[ Price : $8.95]
Advamed praises a bipartisan federal budget deal that would release user fees that were caught up in the sequestration and repeal ...[ Price : $8.95]
Orexigen Therapeutics resubmits its NDA for weight-loss drug Contrave (naltrexone/bupropion) after reporting last month a positive...[ Price : $8.95]
FDA clears an Ethicon Endo-Surgery 510(k) for its Harmonic Focus+ Shears with Adaptive Tissue Technology for use in several surgic...[ Price : $8.95]
CDER Office of New Drugs director John Jenkins says the Center has approved 26 new molecular entities (NME) through 12/6 and will ...