FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Seeks Comments on Emerging Science and Technology

[ Price : $8.95]

Federal Register Notice: FDA seeks public comments on emerging issues and cross-cutting scientific advances that may impact FDA pr...

Accelerated Approval for Lilly Sarcoma Drug

[ Price : $8.95]

FDA grants accelerated approval to Eli Lilly for its soft tissue sarcoma drug Lartruvo (olaratumab) and its use with chemotherapy ...

Hacked Clinton Email Implicates FDA in Irregularities

[ Price : $8.95]

A Hillary Clinton presidential campaign hacked email released by Wikileaks shows how former president Bill Clinton and other top D...

FDA Approves Genentechs Tecentriq for Lung Cancer

[ Price : $8.95]

FDA approves Genentechs Tecentriq (atezolizumab) for treating people with metastatic non-small cell lung cancer.

Comments Sought on PMA Information Collection Requirements

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on extending a collection of information on requirements for medical device PMA submis...

FDA Determines Regulatory Review Period for Repatha

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Amgens Repatha (evolocumab) for patent extension purposes...

CBER Changes Organizational Structure

[ Price : $8.95]

CBER changes its organizational structure to become more efficient at its regulatory duties.

AstraZeneca Resubmits NDA for Hyperkalemia Drug

[ Price : $8.95]

FDA accepts an AstraZeneca NDA re-submission for sodium zirconium cyclosilicate (ZS-9), indicated for treating hyperkalemia (high ...

FDA Clinical Hold on Reneneron/Teva Back Pain Drug

[ Price : $8.95]

FDA places a clinical hold on a Regeneron Pharmaceuticals and Teva Pharmaceutical Industries Phase 2b clinical trial of fasinumab ...

CDER Denies PTC Therapeutics Appeal on Duchenne Drug

[ Price : $8.95]

CDERs Office of Drug Evaluation 1 denies a PTC Therapeutics appeal of a 2/22 refuse-to-file letter issued by the Division of Neuro...