FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Dizal NDA for Lung Cancer Drug

[ Price : $8.95]

Dizal Pharmaceutical submits an NDA for sunvozertinib for treating locally advanced or metastatic non-small cell lung cancer.

Neurotech Review Extension on Retinal Disease BLA

[ Price : $8.95]

FDA extends its review of a Neurotech Pharmaceuticals BLA for NT-501 (revakinagene taroretcel) as a treatment for macular telangie...

Darxalex Faspro sBLA for Smoldering Multiple Myeloma

[ Price : $8.95]

Johnson & Johnson files a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) and its use for treating adult...

Bayers Medrad Centargo CT Injection Cleared

[ Price : $8.95]

FDA clears a Bayer 510(k) for its Medrad Centargo CT Injection System, a multi-patient injector for use in computed tomography.

Allogene Reports Encouraging CAR-T Therapy Data

[ Price : $8.95]

Allogene Therapeutics reports encouraging response rate data for its investigational ALLO-316 in advanced renal cell carcinoma, bu...

Model-Informed Drug Development Comments

[ Price : $8.95]

Four stakeholders respond to an FDA request for comments on guidance development and engaging with stakeholders on model-informed ...

Electa Instrument Recalls Biopsy Needle Kits

[ Price : $8.95]

Elekta Instrument AB recalls (Class 1) its Elekta Disposable Biopsy Needle Kit for the Leksell Stereotactic System due to microsco...

How Soon Will Trump Nominate Next FDA Head?

[ Price : $8.95]

FDA watchers need patience as they wait to see who president-elect Donald Trump chooses to nominate as the next FDA commissioner.

IRB Violations Seen in FDA-483s

[ Price : $8.95]

FDA identifies four trends in IRB violations from FDA-483s issued in FY 2023.

Public Citizen Blasts Potential Drug Approval Change

[ Price : $8.95]

Public Citizen preemptively criticizes expected 2025 legislation to authorize FDA to approve drugs for rare diseases based on subs...