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Neurovalens Anxiety Device Cleared

[ Price : $8.95]

FDA clears a Neurovalens 510(k) for the Modius Stress and its use to treat generalized anxiety disorder.

Drug Shortages at Highest Level: ASHP

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The American Society of Health-System Pharmacists says drug shortages are at the highest level since 2001.

Califf Defends FDA Role in Patent Listings

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During a 4/11 hearing , U.S. Representative Ro Khanna (D-CA) criticizes FDA and commissioner Robert Califf for not doing enough to...

Appeals Court Upholds Norwich ANDA Delay

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A federal appeals court affirms a lower court decision barring FDA from approving a Norwich ANDA for a generic form of Salix Xifax...

FDA OKs CAR-T Trial in Children for Lupus

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FDA authorizes Seattle Childrens Therapeutics to launch a CAR T-cell trial to treat lupus in children.

Army Scientific Groups Hemorrhage AI Detector Cleared

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FDA clears a U.S. Army Biotechnology High Performance Computing Software Applications Institute 510(k) for an artificial intellige...

Lisata Orphan Status for Osteosarcoma Drug

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FDA grants Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma.

Italfarmaco Awarded Priority Review Voucher

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Federal Register notice: FDA issues a priority review voucher to Italfarmaco SpA for being the sponsor of a rare pediatric disease...

Par Sues FDA Over BPI Epinephrine Approval

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Par Pharmaceutical asks a court to stop FDA from granting final approval to a BPI epinephrine product that cites a Par product as ...

ODAC to Discuss Minimal Residual Disease Endpoint

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FDA asks the Oncologic Drugs Advisory Committee to consider whether minimal residual disease is an appropriate intermediate clinic...