FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guide on Standardized BIMO eSubmission Data

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Standardized Format for Electronic Submission of NDA and BLA Cont...

Update on Baxter Recall of Hemodialysis Transfer Sets

[ Price : $8.95]

FDA updates a Baxter recall (device correction) of its MiniCap Extended Life PD Transfer Sets used in hemodialysis.

GSK Files for Nucala COPD Indication

[ Price : $8.95]

FDA accepts for review a supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance treatment for patients wit...

Simplified Dosing for Cumberlands Acetadote OKd

[ Price : $8.95]

FDA approves a Cumberland Pharmaceuticals supplemental NDA for a simplified dosing regimen of its Acetadote (N-acetylcysteine for ...

Mixed Results on Keytruda Ovarian Cancer Study

[ Price : $8.95]

Merck says a Phase 3 KEYLYNK-001 trial evaluating Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza...

Agios Seeks Expanded Use for Pyrukynd

[ Price : $8.95]

Agios files a supplemental NDA for an expanded indication for its Pyrukynd (mitapivat) for treating adult patients with alpha- or ...

FDA Clears Prostate Tissue Ablator

[ Price : $8.95]

FDA clears an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation.

AbbVie Reports Positive Parkinsons Trial Data

[ Price : $8.95]

AbbVie announces positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as an early Parkinson's dise...

Chimerix Plans Accelerated Approval NDA for Gliomas Drug

[ Price : $8.95]

Chimerix plans to submit an NDA before the end of the year seeking accelerated approval for dordaviprone for treating recurrent H3...

Fresenius Hit With 11-Item FDA-483

[ Price : $8.95]

FDA releases an 11-item Form FDA-483 from a 10/2023 Fresenius Kabi Oncology inspection at the companys Pradesh, India manufacturin...