FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Proposed Rule to Modernize Drug Manufacturing Registration

[ Price : $8.95]

FDA proposed a rule seeks to modernize drug establishment registration requirements by creating a streamlined pathway for distribu...

Agency Sends 3rd Complete Response on Hengrui, Elevar NDA

[ Price : $8.95]

FDA sends Hengrui Pharma and Elevar Therapeutics a third complete response letter for their combination of camrelizumab and rivoce...

FDA Restarts Complete Response Letter Postings

[ Price : $8.95]

FDA resumes posting complete response letters just days after HHS confirmed that new rejection letter releases had been halted tem...

Subcutaneous Sarclisa with On-Body Injector Approved

[ Price : $8.95]

FDA approves a new subcutaneous formulation of Sanofi's anti-CD38 monoclonal antibody Sarclisa (isatuximab-irfc), allowing the the...

FDA Inspection Cites SGS North America Contract Laboratory

[ Price : $8.95]

An FDA inspection of SGS North America's contract testing laboratory identifies significant concerns with the firms laboratory con...

FDA Expands Approval of Keytruda-Enfortumab Vedotin Regimen

[ Price : $8.95]

FDA has expanded the indication for Merck's Keytruda (pembrolizumab), including its subcutaneous formulation Keytruda Qlex (pembro...

FDA Fast Tracks Arialys ART5803

[ Price : $8.95]

FDA grants Fast Track designation to Arialys Therapeutics ART5803 to treat anti-NMDA receptor encephalitis.

White House Looking at 3 Possible FDA Commissioners: Reports

[ Price : $8.95]

Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.

FDA Drug, Biologics Centers Continue Workforce Decline

[ Price : $8.95]

CDER and CBER continue to experience net workforce losses through the first nine months of fiscal year 2026, although hiring impro...

AstraZeneca, Ionis' Wainua Misses Phase 3 Study Endpoint

[ Price : $8.95]

AstraZeneca and Ionis Pharmaceuticals say that their Phase 3 CARDIO-TTRansform trial evaluating Wainua (eplontersen) in patients w...