FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CGMP Violations at Chinas Shantou S.E.Z. Baojie

[ Price : $8.95]

FDA warns Chinas Shantou S.E.Z. Baojie Industry about CGMP violations in its production of finished drugs, some of which may be re...

FDA Doubts May Move Trials Overseas: Report

[ Price : $8.95]

Biotech executives, investors, and consultants say some companies are moving early clinical trials overseas due to fears of instab...

FDA OKs First Oral Therapy for Rare Adrenal Tumors

[ Price : $8.95]

FDA approves a Merck NDA for Welireg (belzutifan), an oral drug for treating adults and pediatric patients aged 12 and older with ...

AbbVies Emrelis Approved for Lung Cancer

[ Price : $8.95]

FDA gives AbbVie accelerated approval for its Emrelis (telisotuzumab vedotin-tllv) for treating certain adult patients with locall...

BrightHeart AI Fetal Heart Ultrasound Checker Cleared

[ Price : $8.95]

FDA clears a BrightHeart 510(k) for the B-Right Views, an artificial intelligence-powered tool that automatically detects the stan...

GAO Pushes Its FDA Recommendations to Kennedy

[ Price : $8.95]

The Government Accountability Office tells HHS secretary Robert F. Kennedy, Jr., about priority recommendations it has made in the...

Malaysias BioAsia Worldwide CGMP Issues

[ Price : $8.95]

FDA warns Malaysias BioAsia Worldwide about CGMP violations in its production of finished drugs, some of which may be regulated as...

Cytokinetics Reports Exercise Data on Heart Drug

[ Price : $8.95]

Cytokinetics reports topline results from its Phase 3 MAPLE-HCM clinical trial showing that aficamten significantly improved exerc...

Hunter Syndrome Gene Therapy Accepted for Review

[ Price : $8.95]

FDA accepts for priority review a Regenxbio BLA seeking accelerated approval for gene therapy RGX-121 (clemidsogene lanparvovec) f...

Indian API Maker Hit with Warning Letter

[ Price : $8.95]

FDA sends Indian active pharmaceutical ingredient manufacturer Mentha & Allied Products a Warning Letter that cites the firm for s...