FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Requires New Seizure Warning for Parkinsons Drugs

[ Price : $8.95]

FDA requires an updated safety warning for Parkinsons drug products containing carbidopa/levodopa due to their potential to cause ...

Pfizer, Valneva to File BLA for Lyme Disease Vaccine

[ Price : $8.95]

Pfizer and Valneva plan to submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more ...

Legal Update Highlights FDAs Guide on 3 Year Exclusivity

[ Price : $8.95]

A legal update from Wilson Sonsini Goodrich & Rosati addresses FDAs release earlier this month of a draft guidance clarifying the ...

Priority Review for Ionis Alexander Disease Drug

[ Price : $8.95]

FDA grants a priority review to an Ionis Pharmaceuticals NDA for zilganersen, an experimental treatment for Alexander disease.

Influencers Drug Promotions Pose Public Health Risks: JAMA

[ Price : $8.95]

A new study published in JAMA Network Open highlights growing public health concerns over prescription drug promotion by social me...

ICH Signals New Standards for Advanced Drug Manufacturing

[ Price : $8.95]

The International Council for Harmonization outlines a roadmap for future global standards on advanced drug manufacturing, highlig...

FDA to Convene Public Meeting on Expanding OTC Drug Access

[ Price : $8.95]

FDA hosts a public meeting next month aimed at exploring ways to expand access to nonprescription medications.

Senator Raises Concerns Over Chinese Biotech Firms in U.S. Clinical Trials

[ Price : $8.95]

U.S. Senator Rick Scott (R-FL) urges FDA and other federal health agencies to review and tighten oversight of clinical trials and ...

FDA OKs Opdivo for Previously Untreated Hodgkin Lymphoma

[ Price : $8.95]

FDA approves Bristol Myers Squibbs Opdivo (nivolumab) for use with doxorubicin, vinblastine, and dacarbazine for adult and pediatr...

FDA Schedules Public Hearing on Commissioners Voucher Program

[ Price : $8.95]

FDA is announcing a 6/12 public hearing to gather input on its Commissioners National Priority Voucher Pilot Program.