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Philips Recalls ECG Mobile Monitoring App

[ Price : $8.95]

Philips recalls its Monitoring Service Application concerning the Mobile Cardiac Telemetry Monitoring (BTPS-1000) system after ide...

Guide on Device PMA/HDE Modular Reviews

[ Price : $8.95]

FDA releases guidance entitled Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) Modular Review.

Rigel Pharma Gets Orphan Status for R289

[ Price : $8.95]

FDA grants Rigel Pharmaceuticals an orphan drug designation for R289 and its use in treating myelodysplastic syndromes.

FDA Turmoil Before Trump: CDER Chief Quits

[ Price : $8.95]

CDER director Patrizia Cavazzoni unexpectedly announces her early retirement effective two days before the new Trump administratio...

18,000 Appalled Physicians Urge Senate Rejection of RFK Jr.

[ Price : $8.95]

Over 18,000 appalled physicians sign an open letter urging the U.S. Senate to reject the nomination of Robert F. Kennedy Jr. to se...

FDA Accepts NDA for Menkes Disease Drug

[ Price : $8.95]

FDA accepts for review a Fortress Biotech NDA for CUTX-101 (copper histidinate) for treating Menkes disease.

Tenpoint Therapeutics Positive Data on Vision Drug

[ Price : $8.95]

Tenpoint Therapeutics reports positive topline results from BRIO-II, the companys second Phase 3 pivotal trial evaluating Brimocho...

CapsoVision Capsule Endoscopy Home Use Cleared

[ Price : $8.95]

FDA clears a CapsoVision 510(k) for its CapsoCam Plus capsule endoscopy system for remote ingestion.

Pfizer Touts Bladder Cancer Drug Data

[ Price : $8.95]

Pfizer reports positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab for combination use with Bacill...

Vertex Cystic Fibrosis NDA Used Priority Voucher

[ Price : $8.95]

Federal Register notice: FDA announces that a priority review voucher was used with the agencys 12/20/2024 approval of Vertex Phar...