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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...

Include Pregnant, Lactating Women in Trials: Report

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A new National Academies report calls on FDA and other federal government entities to take steps to increase the participation of ...

Import Alert Against China Syringe Maker

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In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency issues an import ale...