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Lantern Orphan Status for Pancreatic Cancer Drug

[ Price : $8.95]

FDA grants Lantern Pharma an orphan drug designation for LP-184 and its use in treating pancreatic cancer.

FDA Seeks Consumer Reps for Advisory Panels

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Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting con...

Appeals Court Says Teva Carvedilol Sale Induced Patent Infringement

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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.

OMB Approves 4 Information Collections

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Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budge...

CGMP Violations at BBC Group

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FDA warns Chinas BBC Group about CGMP violations in its production of finished pharmaceuticals, along with unapproved new drug and...

Inspection Finds CGMP Issue at Sanit Technologies

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FDA warns Sanit Technologies about CGMP violations in its production of finished drugs.

Stem Cell Therapy Firm Marketing Unapproved Cellular Products

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FDA cautions Stem Cell Therapy of Las Vegas that it is marketing unapproved cellular products and exosomes.

FDA Clears Surround Medical Systems Dental Imaging

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FDA clears a Surround Medical Systems 510(k) for its Portray dental imaging system, a 2D diagnostic tool that allows 3D tomosynthe...

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.