FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA OKs Pfizer Multiple Myeloma Drug

[ Price : $8.95]

FDA gives Pfizer accelerated approval for Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 ...

Biocon Malaysia Plant Hit with 8-item 483

[ Price : $8.95]

FDA issues Biocon an eight-item Form FDA-483 after an inspection last month at the firms Johor, Malaysia manufacturing facility ci...

Florida Amends FOIA Lawsuit Against FDA

[ Price : $8.95]

Florida amends a lawsuit against FDA charging the agency with violating the Freedom of Information Act by withholding records requ...

Clinical Hold on AML Cell Therapy

[ Price : $8.95]

FDA places a clinical hold on a 2seventy bio Phase 1 study (PLAT-08) of SC-DARIC33 in acute myeloid leukemia after a patient death...

Guide on Off-the-Shelf Software in Devices

[ Price : $8.95]

FDA posts a final guidance entitled Off-The-Shelf Software Use in Medical Devices.

Astellas sNDA Filed for Pediatric Cresemba

[ Price : $8.95]

FDA accepts for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), an azole antifungal drug for tr...

Ceribells ClarityPro For Detecting Seizures

[ Price : $8.95]

FDA clears a Ceribell 510(k) for its new software ClarityPro for diagnosing electrographic status epilepticus in adults.

FDA Warning on 15 Universal Meditech Tests

[ Price : $8.95]

FDA warns the public not to use 15 tests manufactured by Universal Meditech after the company notified the agency that it has stop...

FDA On Parametric Release for Sterile Drugs

[ Price : $8.95]

FDA addresses whether parametric release is an appropriate control strategy for sterile drug products that are not terminally ster...

Genprex Gets Orphan Status for Reqorsa

[ Price : $8.95]

FDA grants Genprex an orphan drug designation for Reqorsa immunogene therapy (quratusugene ozeplasmid) and its use for treating sm...