FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Partial Hold on Blueprints Cancer Drug

[ Price : $8.95]

FDA places a partial clinical hold on a Blueprint Medicines early-stage trial testing its experimental cancer drug because of safe...

Takeda Moving Narcolepsy Drug to Phase 3

[ Price : $8.95]

Takeda says it is moving its narcolepsy Type 1 drug TAK-861 to a Phase 3 trial after reporting positive results from a Phase 2b tr...

FDA Clears Kenota Health IgE Test

[ Price : $8.95]

FDA clears a Kenota Health 510(k) for its Kenota 1 Total IgE [immunoglobulin E] test system.

FDA Debars Punjani Over Imported Generic Viagra

[ Price : $8.95]

Federal Register notice: FDA debars Shanif Abdul Punjani for five years from importing or offering for import any drug into the U....

FDA Extends Review of Dupixent in COPD

[ Price : $8.95]

FDA extends by three months its review of a Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment...

Final Rule Allows Imported Device Destruction

[ Price : $8.95]

Federal Register final rule: FDA issues a regulation to implement its authority to destroy a device valued at $2,500 or less that ...

Gilead Misses on Trodelvy Confirmatory Study

[ Price : $8.95]

Gilead Sciences says it will be discussing with FDA a failed confirmatory study of accelerated-approval Trodelvy (sacituzumab govi...

FDA Raises Safety/Efficacy Issues with Lykos PTSD Drug

[ Price : $8.95]

An FDA advisory committee briefing document reveals reviewer concerns about safety and efficacy issues in a Lykos Therapeutics NDA...

Moderna RSV Vaccine Approved by FDA

[ Price : $8.95]

FDA approves a Moderna BLA for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus vaccine for adults aged 60 years and older...

FDA Approves Next-Gen Recell Device

[ Price : $8.95]

FDA approves an Avita Medical PMA supplement for the Recell GO System, its next-generation autologous cell harvesting device.