FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Phelan-McDermid Therapy Given Rare Disease Status

[ Price : $8.95]

FDA awards Neuren Pharmaceuticals a rare pediatric disease designation for its drug candidate NNZ-2591 and its use in treating Phe...

Diversity Action Plans Information Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection entitled Diversity Action Plans (DAPs) for Clinical Studi...

7 Observations in Leiters Health FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with seven observations from an inspection at the Englewood, CO-based Leiters Health outsourcing fac...

FDA Discourages BOT/BAL Accelerated Approval

[ Price : $8.95]

FDA recommends that Agenus not submit its BOT/BAL colorectal cancer treatment for accelerated approval.

Zydus Gets Official Action Indicated on Recent Inspection

[ Price : $8.95]

FDA classifies as official action indicated an April inspection of Zydus Lifesciences injectables manufacturing facility at Jarod,...

Aveo Phase 3 Trial Misses Primary Endpoint

[ Price : $8.95]

Aveo Oncology says its Phase 3 trial of Fotivda plus BMS Opdivo in some renal cell cancer patients did not meet the progression-fr...

Globus Knee Arthroplasty Cleared for ExcelsiusFlex

[ Price : $8.95]

FDA clears a Globus Medical 510(k) for its ExcelsiusFlex with total knee arthroplasty option.

Breakthrough Status for Heart Failure Device

[ Price : $8.95]

FDA grants Restore Medical a breakthrough device designation for its ContraBand device and its use in treating certain heart failu...

Phathom Pharma Heartburn Drug Expanded Use

[ Price : $8.95]

FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) 10 mg tablets for relieving heartburn associated with non-ero...

2 More Warning Letters for Chinese Plastic Syringes

[ Price : $8.95]

FDA says two additional Warning Letters have been issued to Chinese medical device firms as part of its evaluation of defective pl...