FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

ABK Biomedical Gets Breakthrough Status

[ Price : $8.95]

FDA grants ABK Biomedical a breakthrough device designation for its proposed Eye90 microspheres and its use in treating patients l...

Oncology Center Pact on Real-world Evidence

[ Price : $8.95]

FDAs Oncology Center of Excellence and real-world evidence company Syapse renew a four-year agreement to collaboratively develop a...

West Pharma Vial2Bag Admixture Device Cleared

[ Price : $8.95]

FDA clears a West Pharmaceutical Services 510(k) for its Vial2Bag Advanced 13mm admixture device.

FDA Puts Clinical Hold on Genentech MS Studies

[ Price : $8.95]

FDA issues a clinical hold on a Genentech multiple sclerosis clinical development program for fenebrutinib due to liver injury con...

FDA Urges ClinicalTrials.gov Compliance

[ Price : $8.95]

FDA warns that it is continuing to advance its compliance activities associated with required clinical trial information postings ...

Lillys Jaypirca Gains OK in Leukemia/Lymphoma

[ Price : $8.95]

FDA grants Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) 100 mg & 50 mg tablets for treating certain adult patients ...

Pressing Need for Alternative Inspections: Researchers

[ Price : $8.95]

University researchers say there is a pressing need to explore alternative methods for inspecting overseas and domestic drug manuf...

Priority Voucher Awarded to Genzyme

[ Price : $8.95]

Federal Register notice: FDA announces that it has issued a priority review voucher to Genzyme after gaining a qualified approval ...

CBER Modifies Organization Structures in 2 Offices

[ Price : $8.95]

Federal Register notice: CBER modifies the organizational structures in the Office of Blood Research and Review and the Office of ...

Travere sNDA for Filspari Full Approval

[ Price : $8.95]

FDA tells Travere Therapeutics that data appear to support a supplemental NDA to convert the companys accelerated approval to full...