FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Panel Backs Sickle Cell Gene Therapy Safety

[ Price : $8.95]

FDAs Cellular, Tissue, and Gene Therapies Advisory Committee supports Vertex Pharmaceuticals and CRISPR Therapeutics safety assess...

FDA Expects Increasing Cannabis Research

[ Price : $8.95]

An FDA post reviews 50 years of agency involvement in cannabis research and predicts the increase seen in recent years will contin...

Unlicensed Wholesaler Sentenced to Prison

[ Price : $8.95]

A Florida federal judge sentences Marina Sievert to two years in federal prison for mail fraud and introducing into interstate com...

Tonix Shuts Down Depression Drug Development

[ Price : $8.95]

Tonix Pharmaceuticals discontinues the development program for major depressive disorder candidate TNX-601 ER based on disappointi...

New FDA Off-Label Guide Has Challenges: Lawyers

[ Price : $8.95]

Sidley Austin attorneys pull five takeaways, including challenges, from a recent FDA draft guidance on off-label communications be...

FDA Sends 8-item 483 to NATCO Pharma

[ Price : $8.95]

FDA issues NATCO Pharma an eight-item Form FDA-483 after concluding an inspection of the firms Telangana, India, manufacturing fac...

Multiple Violations at WAVi Co.

[ Price : $8.95]

FDA warns Denver, CO-based WAVi Co. about multiple violations in its manufacturing and distribution of the WAVi Desktop, an unappr...

Stakeholders Views on FRAME

[ Price : $8.95]

FDA reports on stakeholder feedback on the agencys Framework for Regulatory Advanced Manufacturing Evaluation.

Clinical Hold Lifted on Mersanas XMT-2056

[ Price : $8.95]

FDA lifts a clinical hold against Mersana Therapeutics Phase 1 clinical trial of XMT-2056, a systemically administered Immunosynth...

Sage Huntingtons Drug Gets Orphan Status

[ Price : $8.95]

FDA grants Sage Therapeutics an orphan drug designation for SAGE-718 and its use in treating Huntingtons disease.