FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Hold Lifted on Iovance Lung Cancer Trial

[ Price : $8.95]

FDA removes a partial clinical hold on Iovance Biotherapeutics IOV-LUN-202 trial investigating the companys LN-145 TIL cell therap...

SpringWorks Rolling NDA for Mirdametinib

[ Price : $8.95]

SpringWorks Therapeutics commences a rolling NDA for mirdametinib, an investigational MEK inhibitor for treating pediatric and adu...

Oregon Medical Cited Over Social Media Claims

[ Price : $8.95]

CBER cites Oregon Medical Centers in an untitled letter over claims it is making on social media sites Facebook and Youtube about ...

Boston Scientific PMA OKd for Stent

[ Price : $8.95]

FDA approves a Boston Scientific PMA for the AGENT Drug-Coated Balloon (DCB), indicated for treating coronary in-stent restenosis ...

Fresh Allograft Heart Valves Regulated by FDA

[ Price : $8.95]

FDA affirms its regulation of fresh allograft heart valves in a just-posted letter to healthcare professionals.

Endo Hit with $2 Billion Fine Over Opioid Sales

[ Price : $8.95]

Endo Health Solutions agrees to plead guilty in federal court and pay over $2 billion in penalties to resolve criminal and civil i...

FDA Denies Approval/Hearing on Vanda Stalled sNDA

[ Price : $8.95]

FDA declines to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) for treat...

Datex-Ohmeda Air Compressor Recall is Class 1

[ Price : $8.95]

FDA classifies as Class 1 a Datex-Ohmeda recall of its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) afte...

Allecra NDA Approval for Antibiotic

[ Price : $8.95]

FDA approves an Allecra Therapeutics NDA for Exblifep (cefepime/enmetazobactam) for treating complicated urinary tract infections.

Class 1 Correction Recall on Electrodes Updated

[ Price : $8.95]

FDA updates a Class 1 recall (correction) of Megadyne Medical Products Mega Soft patient return electrode models to reiterate the ...