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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...

FDA to Review Agios Pyrukynd sNDA

[ Price : $8.95]

FDA says it will review an Agios sNDA for a new Pyrukynd indication and sets a 9/7 PDUFA action date.

FDA Puts Marengos Invikafusp on Fast Track

[ Price : $8.95]

FDA grants fast track designation to Marengos invikafusp T cell activator for some colorectal cancers.

FDA Clears ZuriMED Rotator Cuff Reinforcer

[ Price : $8.95]

FDA clears a ZuriMED Technologies 510(k) for the FiberLocker System for rotator cuff repair reinforcement.

Priority Voucher Awarded to Neurocrine Biosciences

[ Price : $8.95]

Federal Register notice: FDA announces it has issued a priority review voucher to Neurocrine Biosciences because its 12/13 NDA app...

Fresenius Recalls Ivenix Infusion Pumps

[ Price : $8.95]

Fresenius Kabi recalls its Ivenix Infusion System due to potential pneumatic valve failures that may cause the pump to stop an act...

J&J Pauses Varipulse Rollout

[ Price : $8.95]

Johnson & Johnson says it is pausing the limited U.S. rollout of its new Varipulse ablation technology while it investigates the r...