FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Fast Track for Celladon Heart Failure Drug

[ Price : $8.95]

FDA grants fast track status to Celladon Corp. for its investigational drug Mydicar and its use in treating advanced heart failure...

Public Citizen Dismisses Clinical Trial Revamp Proposal

[ Price : $8.95]

Public Citizen says a proposal published in Science by former Intel CEO Andrew Grove to restructure clinical trials in the U.S. is...

2 More Studies Find No Increased CV Risk with ADHD Meds

[ Price : $8.95]

FDA says two new large studies involving drugs used for treating Attention-Deficit/Hyperactivity Disorder (ADHD) have not shown an...

FDA, EMA Begin Sharing Inspection Reports

[ Price : $8.95]

FDA and the European Medicines Agency begin next month relying on each others GMP surveillance inspection reports for certain drug...

FDA OKs Lannett Generic Antihypertensive

[ Price : $8.95]

FDA approves a Lannett ANDA for triamterene with hydrochlorothiazide 37.5/25 mg capsules, a generic of SmithKline Beechams Dyazide...

Nektar Breast Cancer Drug Enters Phase 3 Trial

[ Price : $8.95]

Nektar begins a Phase 3 global clinical trial to evaluate its NKTR-102 as a single agent in women with metastatic breast cancer.

FDA OKs Elanco sNADA for Bovine Respiratory Disease

[ Price : $8.95]

Federal Register Final rule: FDA approves an Elanco sNADA for using tilmicosin for controlling bovine respiratory disease in group...

FDA Publishes Candidates for Performance Review Board

[ Price : $8.95]

Federal Register Notice: FDA publishes a list of members that may be named to its Senior Executive Performance Review Board.

Dako, Genentech Collaborate on Drug for Breast Cancer

[ Price : $8.95]

Dako and Genentech sign an agreement to collaborate on regulatory submissions to FDA for Dakos companion diagnostics for a Genente...

FDA Defends Extra 2 Months to Review PDUFA Submissions

[ Price : $8.95]

FDA defends a two-month extension in PDUFA submission review times under a proposed agreement reauthorizing the user fee program.