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Dont Change 180-day Generic Exclusivity: Yale Journal

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Researchers say they see no evidence of continuing problems with generic drug 180-day exclusivity parking that require a congressi...

Astellas ASPIRO Trial Patient Dies

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Astellas says an ASPIRO trial patient whose serious adverse event led to the trial being paused and an FDA clinical hold has died.

Scalise, Comer Ask FDA About Biden Booster Shot Push

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Two leading House Republicans ask FDA for information on the pressure they say may have come from the White House to approve Covid...

FDA Sees Patents Boosting Drug Competition

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FDA acting commissioner Janet Woodcock asks the U.S. Patent and Trademark Office to open a dialog on how the two agencies can work...

Jacobus Pharma Recalls 3 Ruzurgi Lots

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Jacobus Pharmaceutical recalls three lots of Ruzurgi (amifampridine) 10 mg tablets due to potential contamination with yeast, mold...

inTravent SoloPass Brain Imager Cleared

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FDA clears an inTravent Medical Partners 510(k) for the SoloPass system for aiding in the frontal placement of intra-ventricular c...

Axsome NDA Filed for Migraine Therapy

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FDA accepts for review an Axsome Therapeutics NDA for AXS-07 (meloxicam-rizatriptan) for treating migraine headaches.

Nyxoah Breakthrough Status for Apnea Device

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FDA grants Nyxoah a breakthrough device designation for its Genio bilateral hypoglossal nerve stimulation system and its use in tr...

FDA Clears Expanded Tactoset Indication

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FDA clears Anika Therapeutics Tactoset for an expanded indication.

Clinical Hold Lifted on Hereditary Angioedema Trial

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FDA removes a clinical hold against KalVista Pharmaceuticals and its Phase 2 clinical trial of KVD824 for oral prophylactic treatm...