FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Boehringer Ingelheim Fined $931,000 for Lost Pradaxa Files

[ Price : $8.95]

An Illinois federal judge fines Boehringer Ingelheim $931,000 over Pradaxa development and marketing files it is unable to produce...

FDA Still Has Dapagliflozin Questions

[ Price : $8.95]

FDA medical reviewers say they cant be certain from updated study information that Bristol-Myers Squibbs diabetes drug dapaglifloz...

FDA Seeks to Phase-out Antimicrobials in Food Animals

[ Price : $8.95]

FDA asks antimicrobial drug manufacturers to revise their labels under a voluntary plan to help phase out human-use antibiotics in...

FDA Seeks OTC Topical Anesthetic Labeling Changes

[ Price : $8.95]

FDA asks for labeling changes in all OTC topical antiseptic drug products indicated for preoperative or pre-injection skin prepara...

Cerdelga to Get Priority Review for Gaucher Disease

[ Price : $8.95]

FDA approves a six-month priority review for Genzymes NDA for Cerdelga to treat adult patients with Gaucher Disease Type 1.

CSL Behring Opposes Berinert, Cinryze Petition

[ Price : $8.95]

CSL Behring tells FDA it opposes a citizen petition asking the agency to impose new safety measures on Berinert and Cinryze.

Federal Budget Deal Frees Up Sequestered User Fees

[ Price : $8.95]

Advamed praises a bipartisan federal budget deal that would release user fees that were caught up in the sequestration and repeal ...

Orexigen Re-files NDA for Weight-loss Drug

[ Price : $8.95]

Orexigen Therapeutics resubmits its NDA for weight-loss drug Contrave (naltrexone/bupropion) after reporting last month a positive...

FDA Clears Ethicon Surgical Shears

[ 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...

CDER 2013 NME Approvals on Pace for Average Year: Jenkins

[ 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 ...