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FDA Targets Global Web Sites for Illegal Drugs

[ Price : $8.95]

FDA says that during the recent International Internet Week of Action it targeted 465 Web sites that illegally sold potentially da...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Auro Pharmacies.

Safety Alert on Raindrop Near Vision Inlay

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A new safety alert warns against an increased risk of corneal haze associated with Optics Medicals Raindrop Near Vision Inlay.

Regenerons Dupixent Approved for Asthma

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FDA approves Regenerons Dupixent dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 ye...

Review Extended for sBLA for Opdivo/Yervoy

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FDA extends by three months its review of a Bristol-Myers Squibb supplemental BLA for an indication in metastatic first-line non-s...

Allergenic Products Advisory Panel Meeting Canceled

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Federal Register notice: FDA cancels an 11/7 Allergenic Products Advisory Committee meeting that was scheduled to discuss the use ...

Modified Publication for Device Consensus Standards

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Federal Register notice: FDA makes available a publication containing modifications to the list of standards it recognizes for use...

Approval Withdrawn for 20 NDAs

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Federal Register notice: FDA withdraws the approval of 20 NDAs from multiple applicants after they notified the agency that the dr...

Regulatory Review Period Determined for Imfinzi

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for MedImmunes Imfinzi ...

Former FDA Associate Chief Counsel Joins Ropes & Gray

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Former FDA Associate Chief Counsel for Enforcement Beth Weinman joins Ropes & Gray at its Washington, D.C. office as counsel in th...