FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Vertex Reports Positive Interim Phase 3 Data for Povetacicept

[ Price : $8.95]

Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept signific...

Capricors Duchenne Cell Therapy BLA Resubmitted

[ Price : $8.95]

FDA accepts for review a Capricor Therapeutics BLA resubmission for its experimental cell therapy deramiocel, intended to treat he...

FDA OKs Leucovorin for Ultra-Rare Brain Disorder, But Not Autism

[ Price : $8.95]

FDA approves an expanded use of GSKs Wellcovorin (leucovorin calcium) tablets for treating cerebral folate deficiency in adult and...

Xenon Reports Positive Phase 3 Data for Epilepsy Drug

[ Price : $8.95]

Xenon Pharmaceuticals says its experimental epilepsy drug azetukalner met the primary endpoint in a late-stage clinical trial in p...

Updated Guidance Clarifies Biosimilar Development Requirements

[ Price : $8.95]

FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.

Incyte Gets Complete Response Over Catalent Inspection Issues

[ Price : $8.95]

FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspectio...

Group urges Pfizer to Retract Threat on Drug Supplies

[ Price : $8.95]

Consumer advocacy group Public Citizen urges Pfizer to commit to maintaining access to its medicines in Europe after comments by C...

Roche Breast Cancer Drug Misses Endpoint in Late-Stage Trial

[ Price : $8.95]

Roche reports that its investigational breast cancer drug giredestrant failed to significantly extend progression-free survival in...

FDA Meets with States to Advance Canada Importation Plan

[ Price : $8.95]

FDA says it recently held a meeting with several states to discuss implementation of a program that would allow the importation of...

Ipsen Withdraws Tazverik Over Safety Data

[ Price : $8.95]

Ipsen voluntarily withdraws Tazverik (tazemetostat) from the market based on emerging data from the ongoing Phase 1b/3 SYMPHONY-1 ...