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Human Drugs

WLF Asks Supreme Court to Overturn 3rd Circuit Decision

Washington Legal Foundation asks the Supreme Court to review an appeals court decision it says will make it virtually impossible to settle drug patent...

Medical Devices

IlluminOss Bone Stabilization System Cleared by FDA

FDA provides de novo clearance for IlluminOss Medicals IlluminOss Bone Stabilization System for treating impending and actual pathological fractures o...

Medical Devices

Pulmonx Files PMA for Emphysema Device

Pulmonx Corp. files a PMA for the Zephyr Endobronchial Valve (EBV), a removable device designed to treat severe emphysema.

Gottlieb Praises Drug Approvals, Other 2017 Successes

FDA commissioner Scott Gottlieb hails the agencys record of drug approvals in 2017.

Human Drugs

pSivida Files NDA for Eye Disease

pSivida Corp. files an NDA for Durasert, a three-year sustained-release implant containing the corticosteroid fluocinolone acetonide for treating post...

FDA General

FDA Enforcement Drops Under Trump Administration

The Trump Administration brings a big drop in FDA enforcement actions, cutting Warning Letters by 12% and inspections by 13%.

Human Drugs

Merck Files 2 NDAs on New HIV Drug

FDA accepts for review two Merck NDAs for doravirine, the companys investigational non-nucleoside reverse transcriptase inhibitor for treating HIV-1 i...

Medical Devices

STS Medical Composite Sinus Stent Cleared

FDA clears an STS Medical 510(k) for its composite sinus stent.

Human Drugs

Study Finds Birth Defect Risks with ADHD Drugs

A new study suggests that pregnant women who take certain drugs for treating attention deficit hyperactivity disorder have a higher risk that their ba...

Human Drugs

Petition Denied on Forteo ANDA Restrictions

FDA denies a 10/2017 Amneal Pharmaceuticals petition asking it not to approve any ANDAs for generic forms of its Forteo (teriparatide [rDNA origin]) i...