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Vaccines Advisory Committee Plans 10/9 Meeting

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Federal Register notice: FDA has announced a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to hear a la...

FDA Finalizing ALS Guidance Next Month

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FDA plans to release a final guidance on developing amyotrophic lateral sclerosis (ALS) drugs and biologics products by the end of...

FDA Report on Pediatric Labeling in Orphan Drugs

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A new report from FDA examines pediatric labeling on orphan drugs that were approved from 4/1/1999 to 8/31/2018.

FDA Warns Metuchen Pharma on Promotions

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A just-released FDA Warning Letter cites Metuchen Pharmaceuticals over its promotional activities related to erectile dysfunction ...

More Males Needed in Breast Cancer Trials: FDA

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FDA says it wants to start seeing more males included in breast cancer drug trials and using real world data can help.

Akorn Generic Allergy Nasal Spray Approved

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FDA approves an Akorn ANDA for azelastine hydrochloride nasal spray, 0.15%, indicated for relieving symptoms of seasonal allergic ...

2 Vyaire Pulmonary Function Tests Cleared

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FDA clears a Vyaire Medical 510(k) for two of its latest pulmonary function testing technologies: Vyntus ONE and Vyntus BODY with ...

J&J Ordered to Pay $572 Million in Opioid Case

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Oklahoma county judge Thad Balkman rules against Johnson & Johnson and orders it to pay $572 million in the first ruling in the U....

Miracor Heart Device Gains Breakthrough Status

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FDA grants Miracor Medical a breakthrough device designation for its PiCSO Impulse System for treating ST-elevated myocardial infa...

FDA Clears Drawbridge OneDraw A1C Device

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FDA clears a Drawbridge Health 510(k) for the OneDraw A1C Test System, which comprises the OneDraw Blood Collection Device and the...