FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Takeda/Protagonist NDA Gets Priority Review for Polycythemia Vera

[ Price : $8.95]

FDA accepts for priority review a Takeda and Protagonist Therapeutics NDA for rusfertide, positioning the drug as a potential firs...

Pfizer CEO Concerned About FDA Vaccines Chief

[ Price : $8.95]

Pfizer CEO Albert Bourla tells TD Cowen healthcare conference that the leadership of FDAs biologics center is worrisome because it...

Intellia Gets Hold Lifted on MAGNITUDE Phase 3 Trial in ATTR-CM

[ Price : $8.95]

FDA removes a clinical hold against Intellia Therapeutics and its MAGNITUDE Phase 3 trial of nexiguran ziclumeran (nex-z), an expe...

Ex-FDA Leaders Accuse Trump Admin of Distorting Contraceptive Science

[ Price : $8.95]

Three former senior FDA officials tell a federal appeals court that the Trump administration mischaracterized the science on contr...

FDA Employees Told Not to Use Claude AI in Tech Dispute

[ Price : $8.95]

HHS directs FDA and other health agency employees to immediately stop using the artificial intelligence platform Claude after the ...

Synergy Spines Artificial Cervical Disc Approved

[ Price : $8.95]

FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc.

Researcher Critiques FDA Minimal Residual Disease Guidance

[ Price : $8.95]

A leading myeloma researcher says FDAs draft guidance endorsing minimal residual disease as a potential basis for accelerated drug...

User Fee Negotiations Are Hung Up on America First Proposals

[ Price : $8.95]

Drug user fee negotiators confront lingering divisions over FDAs America First proposals and the structure of hiring commitments, ...

DoJ Supports Generic Drug Skinny Label Provision

[ Price : $8.95]

The U.S. Department of Justice (DoJ) says a Federal Circuit ruling on so-called generic drug skinny labels threatens to undermine ...

Rare Disease Developers Welcome FDA Guidance

[ Price : $8.95]

Rare disease drug developers and patient advocates are applauding a series of new guidance documents from FDA that bring long-awai...