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Appeals Court Says Teva Carvedilol Sale Induced Patent Infringement

[ Price : $8.95]

The Federal Circuit Court of Appeals says promotional materials developed by Teva were enough to induce infringement of a GSK carv...

Captains Cloth Selling Unapproved KN95 Masks: FDA

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FDA warns Captains Cloth it is marketing unapproved, adulterated, and misbranded KN95 face masks.

Panel to Discuss Cook Pediatric Esophageal Device

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Federal Register notice: FDA announces a 9/17 Pediatric Advisory Committee to discuss a pediatric-focused safety review of Cook Me...

Docket on Pediatric Product Safety Reviews

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Federal Register notice: FDA establishes a public docket to collect comments related to the post-marketing pediatric-focused safet...

KVK Tech Recalls Pneumonia Antibiotic

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KVK Tech recalls two lots of atovaquone oral suspension, USP 750 mg/5mL based on customer complaints of unusual grittiness in the ...

FDA Accepts 2 Keytruda sBLAs for Review

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FDA accepts for review two Merck supplemental BLAs for its anti-PD-1 therapy Keytruda (pembrolizumab) one for patients with renal...

Lepu Medical Technology Selling Unapproved Covid Tests: FDA

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FDA warns Chinas Lepu Medical Technology it is marketing unapproved Covid-19 test kits in the U.S.

Intended Use Guidance Disappoints Stakeholders: Analysis

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Attorney Patricia Kaufman says many stakeholders will be disappointed by the approach FDA has taken in its new intended use final ...

Boston Scientific Exalt Bronchoscope Cleared

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FDA clears a Boston Scientific 510(k) for its Exalt Model B Single-Use Bronchoscope, designed for use in bedside procedures within...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include BBC Group, Lepu Medical Technology and Sanit Technologies.