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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...

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...

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...

Sumitomo Pharma Gets Fast Track Status for Nuvisertib

[ Price : $8.95]

FDA grants Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk ...