FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Filspari sNDA Accepted for Rare Kidney Disease

[ Price : $8.95]

FDA accepts for review a Travere Therapeutics supplemental NDA for traditional approval of Filspari (sparsentan) for treating foca...

Fujirebio Diagnostics Gets Alzheimers Test Cleared

[ Price : $8.95]

FDA clears a Fujirebio Diagnostics 510(k) for the first in vitro diagnostic device that tests blood in diagnosing Alzheimers disea...

FDA Raises Issues on 4 Cancer Drugs at Panel

[ Price : $8.95]

FDA posts briefing documents outlining issues to be discussed during a two-day (5/20-21) Oncologic Drugs Advisory Committee meetin...

Troriluzole PDUFA Action Date Extended

[ Price : $8.95]

FDA says it is delaying for three months the PDUFA action date for Biohavens troriluzole to treat spinocerebellar ataxia.

FDA Initiatives Help Early-Phase Cancer Trials: Post

[ Price : $8.95]

IQVIA senior director David Cameron says FDA oncology initiatives like Project FrontRunner can help speed innovative cancer treatm...

Roche Companion Diagnostic for AbbVies Emrelis OKd

[ Price : $8.95]

FDA approves Roches Ventana MET (SP44) RxDx Assay, a companion diagnostic to aid in determining MET protein expression in lung can...

Nipro Renal Recalls MedicaLyte Hemodialysis Product

[ Price : $8.95]

Nipro Renal Soultions recalls (Class 1) its MedicaLyte Liquid Bicarbonate Concentrate due to the potential for the presence of vis...

Agency Has Evolved in the Last 10 Years: Verdun

[ Price : $8.95]

CBERs Nicole Verdun tells a Friends of Cancer Research meeting on next-generation therapies that FDA has evolved in the last decad...

Makary Says Vaccine Framework Coming Soon

[ Price : $8.95]

FDA commissioner Marty Makary says the agency is planning to release in the coming days a vaccine development framework to help wi...

Amneals Brekiya Approved for Migraines

[ Price : $8.95]

FDA approves Amneals Brekiya, the only dihydrogotamine mesylate autoinjector available to treat migraine and cluster headaches in ...