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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

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

Commissioners National Priority Voucher Program

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FDA launches the Commissioners National Priority Vouchers to speed drug reviews for companies with products that are aligned with ...

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

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

OIG Hit FDA Accelerated Approvals

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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

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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

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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

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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

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