FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

ViiV Wins Adolescent HIV Use for Dovato

[ Price : $8.95]

FDA approves ViiV Healthcares Dovato (dolutegravir/lamivudine) for treating HIV-1 infection in adolescents with no antiretroviral ...

Stealth Bio NDA for Barth Syndrome Accepted

[ Price : $8.95]

FDA accepts for review a Stealth BioTherapeutics NDA for elamipretide for treating Barth syndrome.

Spirair Nasal Septal Deviation Device Cleared

[ Price : $8.95]

FDA clears a Spirair 510(k) for its SeptAlign system for treating nasal septal deviation.

Carvykti Approved for Expanded Myeloma Use

[ Price : $8.95]

FDA approves a supplemental BLA submitted by Janssen for Carvykti (ciltacabtagene autoleucel) to treat adults with relapsed or ref...

FDA 2nd Complete Response on Parkinsons Drug

[ Price : $8.95]

FDA sends Supernus Pharmaceuticals a second complete response letter on its NDA resubmission for the companys apomorphine infusion...

Nominations Sought for Patient Engagement Panel

[ Price : $8.95]

Federal Register notice: FDA requests nominations for voting members, excluding consumer and industry representatives, to serve on...

Meeting on User Fee Program Financials

[ Price : $8.95]

Federal Register notice: FDA announces a 6/6 public meeting entitled Financial Transparency and Efficiency of the Prescription Dru...

24 Drugs Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that 24 listed drug products were not withdrawn from sale for reasons of safety or effecti...

De Novo for Antibacterial Coated Implants

[ Price : $8.95]

FDA grants Onkos Surgical a de novo marketing authorization for its novel antibacterial coated implants.

Shuffert Debarred for 5 Years

[ Price : $8.95]

Federal Register notice: FDA issues an order to debar for five years Robert Lance Shuffert from importing or offering for import a...