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Multiple Violations at Reset Technology Corp.

[ Price : $8.95]

FDA warns Irving, TX-based Reset Technology Corp. about Quality System and other violations in its production of two dental device...

Elevidys Shipping Nixed After 2nd Liver‑Failure Death

[ Price : $8.95]

Sarepta Therapeutics halts shipments of its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to nonR...

CGMP Issues at Indias Kenil Healthcare

[ Price : $8.95]

FDA warns Indias Kenil Private Healthcare about CGMP violations in its production of finished drugs.

Pfizers Talzenna Gets Updated Label

[ Price : $8.95]

FDA approves updated labeling on Pfizers s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with metastati...

Roche Advancing Parkinsons Drug Into Phase 3

[ Price : $8.95]

Roche moves prasinezumab into a Phase 3 trial after two mid‑stage trials and their open‑label extensions hinted at a d...

Milestone Pharma Files NDA Resubmission for Cardamyst

[ Price : $8.95]

Milestone Pharmaceuticals submits its response to a March-issued FDA complete response letter on the companys NDA for irregular he...

Zyno Medical Recalls Infusion Pumps

[ Price : $8.95]

Zyno Medical recalls certain Z-800 infusion pumps because they were released to customers with incorrect software versions.

Qalitex Warns of Growing FDA-Amazon Enforcement Overlap

[ Price : $8.95]

Qalitex Laboratories issues an alert to dietary supplement and wellness product sellers on Amazon about a growing overlap between ...

AbbVie's Venetoclax Fails to Improve Survival in Trial

[ Price : $8.95]

An AbbVie Phase 3 (VERONA) clinical trial evaluating venetoclax in combination with azacitidine for newly diagnosed higher-risk my...

Incyte Reports Positive Data on Neoplasm Drug

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Incyte reports the first positive clinical data from studies evaluating a novel, first-in-class targeted monoclonal antibody in pa...