FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Unicycive Therapeutics NDA for Oxylanthanum

[ Price : $8.95]

FDA accepts for review a Unicycive Therapeutics 505 (b) (2) NDA for oxylanthanum carbonate and its use in treating hyperphosphatem...

FDA Clears Vertiwedge Intraosseous Device

[ Price : $8.95]

FDA clears a Foundation Surgical 510(k) for its Vertiwedge Intraosseous, a motion-sparing partial vertebral body replacement devic...

Clinical Hold on Novavax Vaccines Lifted

[ Price : $8.95]

FDA removes a clinical hold on a Novavax IND for its Covid-19-influenza combination and stand-alone flu vaccine candidates.

Autolus Wins OK for Leukemia CAR-T Theray

[ Price : $8.95]

FDA approves an Autolus Therapeutics BLA for Aucatzyl (obecabtagene autoleucel), a CAR-T therapy for treating adult patients with ...

Darxalex Faspro sBLA for Smoldering Multiple Myeloma

[ Price : $8.95]

Johnson & Johnson files a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) and its use for treating adult...

Bayers Medrad Centargo CT Injection Cleared

[ Price : $8.95]

FDA clears a Bayer 510(k) for its Medrad Centargo CT Injection System, a multi-patient injector for use in computed tomography.

Allogene Reports Encouraging CAR-T Therapy Data

[ Price : $8.95]

Allogene Therapeutics reports encouraging response rate data for its investigational ALLO-316 in advanced renal cell carcinoma, bu...

Group Criticizes FDA Foot Dragging on Phenylephrine

[ Price : $8.95]

Advocacy group Public Citizen criticizes FDA for dragging its feet in removing phenylephrine from the U.S. market.

Dizal NDA for Lung Cancer Drug

[ Price : $8.95]

Dizal Pharmaceutical submits an NDA for sunvozertinib for treating locally advanced or metastatic non-small cell lung cancer.

Neurotech Review Extension on Retinal Disease BLA

[ Price : $8.95]

FDA extends its review of a Neurotech Pharmaceuticals BLA for NT-501 (revakinagene taroretcel) as a treatment for macular telangie...