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GE Healthcare Recalls Newborn Incubators

[ Price : $8.95]

GE Healthcare has recalled its Giraffe Omnibed Carestation and Incubator Carestation due to the potential for excessive formaldehy...

Groups Urge Rare Disease Voucher Reauthorization

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A letter from dozens of patient advocacy groups urges congressional leaders to pass the Creating Hope Reauthorization Act, which w...

FDA Loses Again in FOIA Suit on Vaccine Records

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A Texas federal court rules against FDA in an ongoing Freedom of Information Act lawsuit and it must now produce EUA supporting do...

FDA Finds Lab Issues at Musk Plant

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Reuters says FDA has informed Congress about a 2023 agency inspection at Elon Musks Neuralink that found animal lab issues that wa...

Updated Accelerated Approval Guidance

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FDA publishes a draft guidance updating its accelerated approval policies and procedures based on new authority from the 2023 Cons...

Genentech sBLA for Columvi Accepted for Review

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FDA accepts for review a Genentech supplemental BLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin...

29 Drugs Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that 29 drug products listed in the notice were not withdrawn from sale for reasons of saf...

FDA Approves AZs Lung Cancer Drug Imfinzi

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FDA approves AstraZenecas Imfinzi to treat some adults with limited-stage small cell lung cancer.

Rayner Wants Generic Omidria Restrictions

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Rayner Surgical petitions FDA to restrict approval of any ANDA citing Omidria as the reference-listed drug.

Protara Reports Positive Data on Bladder Cancer Drug

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Protara Therapeutics reports encouraging data from a Phase 2 trial of its cell-based TARA-002 in certain high-risk non-muscle inva...