FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Biogen, Denali Halt Development of Parkinsons Drug in Idiopathic Disease

[ Price : $8.95]

Biogen and Denali Therapeutics limit the development of their experimental Parkinsons disease drug BIIB122 after the therapy faile...

FDA OKs Datroway for Triple-Negative Breast Cancer

[ Price : $8.95]

FDA approves Daiichi Sankyos Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative bre...

Chronic Hepatitis Delta Virus Infection Treatment Approved

[ Price : $8.95]

FDA has approved Gilead Sciences Hepcludex (bulevirtide-gmod) for treating chronic hepatitis delta virus (HDV) infection, marking ...

Early Alert on Abiomed Heart Pump Controller Software Problem

[ Price : $8.95]

FDA issues an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by ...

Guidance Raises Expectations for Form 483 Responses, Expert Says

[ Price : $8.95]

A regulatory expers says FDAs recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufactu...

Bolton Thoracic Stent Recall is Class 1: FDA

[ Price : $8.95]

FDA says a Bolton Medical recall of its RelayPro thoracic stent graft system is Class 1.

Clinical Electronic Structured Protocol Template

[ Price : $8.95]

FDA publishes for reference only an International Council for Harmonization template on a clinical electronic structured harmonize...

Comments on Increasing Access to Non-Prescription Drugs

[ Price : $8.95]

Four stakeholders comment to FDA on ways to increase patient access to nonprescription drugs.

FDA to Convene Panel on Modernas mRNA Flu Vaccine

[ Price : $8.95]

FDA announces a 6/18 advisory committee meeting to review Modernas controversial mRNA-based seasonal influenza vaccine.

RFK Jr. Ignores Hill Request on Anti-Vax Activist HHS Role

[ Price : $8.95]

HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime ...