FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Seeks Faster IND-To-Approval Timelines, Expanded OTC Access

[ Price : $8.95]

FDA commissioner Marty Makary says the agency is prioritizing efforts to accelerate drug development timelines beginning at the IN...

FDA Extends Review Timeline for Orca Bios Cell Therapy Orca-T

[ Price : $8.95]

FDA extends by three months its review of an Orca Bio BLA for its experimental cell therapy Orca-T, indicated for treating a range...

Xbrane Plans Resubmission of Lucentis Biosimilar by June

[ Price : $8.95]

Xbrane Biopharma says it plans to resubmit a BLA before June for ranibizumab, a biosimilar copy of Genentechs Lucentis, which is i...

Lillys Oral Obesity Drug Foundayo Wins Approval

[ Price : $8.95]

Eli Lilly wins FDA approval for Foundayo (orforglipron), a once-daily oral treatment for adults with obesity or those who are over...

FDA-483 Not a Proxy for Overall Quality: Califf

[ Price : $8.95]

Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying issues that companies should c...

CGMP Deviations in Henan Lvyuan Inspection

[ Price : $8.95]

FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing prac...

Modernize DTC Ads with QR Code: WLF

[ Price : $8.95]

A Washington Legal Foundation background document suggests that Congress change direct-to-consumer disclaimer rules to recognize t...

NIH-Funded Study to Assess GLP-1 Drugs in Alzheimers

[ Price : $8.95]

Researchers at the University of Cincinnati begin a new study to investigate whether widely used diabetes and weight-loss drugs co...

FDA Says Proposed Drug Import Guidance Unwarranted

[ Price : $8.95]

FDA denies a 2024 Aimed Alliance petition asking for a guidance on human drug importation by alternative funding programs.

Mitapivat Moving Toward Accelerated Approval in Sickle Cell: Agios

[ Price : $8.95]

Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell disease, following a pre-submission ...