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FDA Approves Clinuvels Phototoxic Reactions Drug

[ Price : $8.95]

FDA approves a Clinuvel NDA for Scenesse (afamelanotide) for increasing pain-free light exposure in adult patients with a history ...

California Law Combats Pay-for-Delay Agreements

[ Price : $8.95]

California becomes the first state in the nation to approve a bill to combat so-called pay-for-delay agreements between innovator ...

NuCare Pharmaceuticals Listing Violations

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FDA warns NuCare about many instances in which its listing information does not comply with applicable requirements.

Jury Awards $8 Billion in Risperdal Case

[ Price : $8.95]

A Philadelphia jury delivers an $8 billion punitive verdict against Johnson & Johnson and its alleged improper marketing of the an...

Animal Drug Regs Amended for Recent Approvals

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Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for NADAs and ANADAs during...

Medtronic PMA Supplement for InterStim Micro/Leads

[ Price : $8.95]

Medtronic submits a PMA supplement for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.

Info Collection on IDE Reports/Records

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Federal Register notice: FDA sends to OMB an information collection extension entitled Investigational Device Exemptions Reports a...

FDA Monitors Heparin Makers Due to Swine Fever

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FDA says that heparin manufacturers are reporting that African swine fever in China is not affecting the drugs manufacturing and d...

Pfizer Licenses Investigational Antisense Therapy

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Pfizer licenses Akcea Therapeutics Akcea-AngPtl3-L, an investigational antisense therapy being developed for certain cardiovascula...

Pfenex NDA Approved for Forteo Copy

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FDA approves a Pfenex Inc. 505(b)(2) NDA for PF708 (teriparatide injection) that referenced Eli Lillys Forteo, indicated for treat...