FDA

Zacks Small Cap Research – MGRM: Monogram Announces it has Received an Additional Information Request (AIR) from the FDA Regarding its Recent 510(k) Submission. – Go Health Pro

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By Thomas Kerr, CFA NASDAQ:MGRM READ THE FULL MGRM RESEARCH REPORT FDA Response to 510(k) Filing On October 6, 2024, Monogram (NASDAQ:MGRM) announced it had received an Additional Information Request (“AIR”) from the U.S. Food and Drug Administration (“FDA”) on September 30, 2024, regarding its 510(k) premarket filing submission for the semi-active mBôs TKA System. … Read more

Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals – Go Health Pro

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Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals – Go Health Pro

The judge in the case, District Judge Mark Pittman, granted the FDA’s request, canceling an October 15 hearing, and ordering the parties to submit a joint status report on November 21. Drugmakers respond The move was celebrated by the Outsourcing Facilities Association (OFA), which filed the lawsuit. “We believe that this is a fair resolution … Read more

Zacks Small Cap Research – CTSO: CytoSorbents Announces Submission of DrugSorb-ATR Application to the FDA – Go Health Pro

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By Thomas Kerr, CFA NASDAQ:CTSO READ THE FULL CTSO RESEARCH REPORT DrugSorb-ATR Submission On October 1, 2024, CytoSorbents (NASDAQ:CTSO) announced the submission of its DrugSorb-ATR medical device De Novo marketing application to the U.S. Food and Drug Administration (FDA) on September 27, 2024. The goal of this product is to reduce the severity of perioperative … Read more

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