FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Orphan Status for Biliary Tract Cancer Drug

[ Price : $8.95]

FDA grants Nuvectis Pharmas NXP800 an orphan drug designation for treating biliary tract cancer.

Pentax Endoscope and Video Processor Cleared

[ Price : $8.95]

FDA clears a Pentax Medical 510(k) for its Inspira 4K video processor and the i20c video endoscope.

FDA Oks Ipsens Sohonos for FOP

[ Price : $8.95]

FDA approves Ipsens Sohonos as the first treatment for adults and some pediatric patients with fibrodysplasia ossificans progressi...

Cardiosave Balloon Pump Recall Class 1: FDA

[ Price : $8.95]

FDA says the Datascope/Maquet/Getinge recall of Cardiosave balloon pumps is Class 1.

BlueWind De Novo for Incontinence Device

[ Price : $8.95]

FDA grants BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for tr...

Workshop on Postapproval Pregnancy Studies

[ Price : $8.95]

Federal Register notice: FDA announces a 9/18-19 public workshop entitled Optimizing the Use of Postapproval Pregnancy Safety Stud...

Vanda Pushes Back on Hetlioz sNDA Hearing Denial

[ Price : $8.95]

A sharply-worded Vanda response to FDA says commissioner Robert Califf should reject a CDER proposed order and either approve Vand...

Priority Review for Serviers Tibsovo sNDA

[ Price : $8.95]

FDA says it will give priority review to a Servier sNDA seeking a new indication for Tibsovo to treat some adult myelodysplastic s...

Abortion Drug Can Remain on Market: Appeals Court

[ Price : $8.95]

The Fifth Circuit Court of Appeals rules that the abortion drug mifepristone can remain on the market while litigation continues.