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Medical Devices

GE Healthcare Recalls Newborn Incubators

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

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Human Drugs

Groups Urge Rare Disease Voucher Reauthorization

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

Biologics

FDA Loses Again in FOIA Suit on Vaccine Records

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

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Medical Devices

FDA Finds Lab Issues at Musk Plant

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

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Human Drugs

Updated Accelerated Approval Guidance

FDA publishes a draft guidance updating its accelerated approval policies and procedures based on new authority from the 2023 Consolidated Appropriati...

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Biologics

Genentech sBLA for Columvi Accepted for Review

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

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Federal Register

29 Drugs Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that 29 drug products listed in the notice were not withdrawn from sale for reasons of safety or effectiveness...

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Human Drugs

FDA Approves AZs Lung Cancer Drug Imfinzi

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

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Human Drugs

Rayner Wants Generic Omidria Restrictions

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

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Human Drugs

Protara Reports Positive Data on Bladder Cancer Drug

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