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3rd Circuit Remands Hundreds of Fosamax Cases

[ Price : $8.95]

The 3rd Circuit Court of Appeals asks a New Jersey federal court to look at hundreds of Fosamax bone fracture cases and determine ...

NeuroOne Thin Film Brain Electrode Cleared

[ Price : $8.95]

FDA clears a NeuroOne Medical Technologies 510(k) to market its thin film cortical electrode technology for temporary (less than 3...

Immunomedics Re-files for Breast Cancer Therapy

[ Price : $8.95]

Immunomedics resubmits its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating certain patients wit...

Reg Review Period for Ultragenyxs Crysvita

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Ultragenyxs Crysvita.

Guide on Clinical Trial Adaptive Designs

[ Price : $8.95]

FDA releases a final guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics.

Impella Heart Pump Survival Data Favorable: FDA

[ Price : $8.95]

FDA says that most recent, interim post-approval study results for the Impella RP System continue to show a favorable survival ra...

Info Collection on Device Pediatric Subpopulations

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension on a requirement for submitting certain pediatr...

21 No-longer-marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 21 ANDAs from multiple applicants after they notified the agency that the drug ...

FDA Orders GREFI to Stop Making Cell/Tissue Products

[ Price : $8.95]

FDA orders Gynecology, Reproductive Endocrinology and Fertility Institute to immediately stop manufacturing cell/tissue products a...

Workshop on Artificial Intelligence in Radiological Imaging

[ Price : $8.95]

FDA announces a 2/25 public workshop entitled Evolving Role of Artificial Intelligence in Radiological Imaging.