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Aldeyra Files NDA Resubmission for Dry Eye Drug

[ Price : $8.95]

Aldeyra Therapeutics resubmits an NDA for reproxalap to treat the signs and symptoms of dry eye disease.

Zhejiang Huahai Pharmaceutical CGMP Issues

[ Price : $8.95]

FDA warns Chinas Zhejiang Huahai Pharmaceutical Co. about CGMP violations in its production of finished drugs.

OIG Hit FDA Accelerated Approvals

[ Price : $8.95]

The latest semiannual report issued by the HHS Office of Inspector General raises questions about specific FDA accelerated drug ap...

FDA Allows Companies to Skip Import Bans: Report

[ Price : $8.95]

A ProPublica investigative report details how a secret small group of FDA officials has approved exemptions for products from over...

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

[ Price : $8.95]

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