FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Hits Philips with 29-page 483 Over Recalled Device

[ Price : $8.95]

An FDA inspection of Philips Respironics results in a 29-page Form FDA-483 based on a Class 1 recall follow-up involving its conti...

Biden Taps Ex-FDA Head Califf as Next Commissioner

[ Price : $8.95]

The Biden Administration chooses former FDA head Robert Califf as its FDA commissioner nominee.

Apellis NDA Planned for Geographic Atrophy

[ Price : $8.95]

Apellis Pharmaceuticals says it will file an NDA during the first half of 2022 for intravitreal pegcetacoplan for treating a blind...

Foreign Study Sites Escape FDA Oversight: Professor

[ Price : $8.95]

A Journal of Clinical Pharmacology study finds that FDA has less oversight of overseas clinical trials that are used to form the b...

PharmaEssentia BLA Approved for Blood Disease

[ Price : $8.95]

FDA approves a PharmaEssentia BLA for Besremi injection to treat adults with polycythemia vera, a blood disease associated with re...

Oklahoma Court Overturns J&J Opioid Case Ruling

[ Price : $8.95]

The Oklahoma Supreme Court says a lower court erred in determining that J&J violated the states public nuisance law in the way it ...

Rivoceranib Gets Orphan Status for Liver Cancer

[ Price : $8.95]

FDA grants Elevar Therapeutics an orphan drug designation for rivoceranib and its use for treating hepatocellular carcinoma.

FDA Accepts Jardiance sNDA for CV Risk Reduction

[ Price : $8.95]

FDA accepts for priority review a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) 10 mg for redu...

Naviswiss Hip Replacement Navigator Cleared

[ Price : $8.95]

FDA clears a Naviswiss 510(k) for its Naviplan, a digital pre-operative planning application to assist orthopedic surgeons in perf...

Novavax Expects U.S. Covid Vaccine Filing Soon

[ Price : $8.95]

Novavax requests a meeting with FDA in advance of filing for approval of its Covid-19 vaccine.