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Human Drugs

Google Watch Cleared for Pulse Loss Detection

FDA clears a Google 510(k) for its Loss of Pulse Detection feature and its use on the Pixel Watch 3.

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Human Drugs

CDER Touts FY 2024 Drug Safety Activities

CDERs 10th yearly drug safety report highlights the FY 2024 establishment of two new units contributing to drug safety.

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Human Drugs

16% Oncology Phase 2 Patients Get Drugs Later OKd

Canadian researchers find that 16% of patients in Phase 2 oncology trials receive treatments that are later approved by FDA for their condition.

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Medical Devices

Abanza WasherCap Mini Fixation Device Cleared

FDA clears an Abanza 510(k) for its WasherCap Mini fixation system for soft tissue repair, including meniscal root repair and anterior cruciate ligame...

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Human Drugs

Regeneron Refiles BLA for Follicular Lymphoma

FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for odronextamab in relapsed/refractory follicular lymphoma.

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Human Drugs

Generic Mifepristone Maker Wants to Defend Suit

GenBioPro, which manufactures FDA-approved generic mifepristone, says it wants to be added to the list of defendants in a suit seeking to ban the drug...

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FDA General

More FDA Cuts Coming Down the Road

Fresh on the heels of staff disruptions caused by the termination of about 1,000 probationary employees, the Trump administration issues a new memo ca...

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Human Drugs

OTC Shampoo Suit Preempted by FDA Monograph

Two Hollingsworth attorneys write in a Washington Legal Foundation post about a California federal court decision tossing state claims against an over...

Biologics

Janssen Vaccines FDA-483

FDA releases the form FDA-483 with five observations from an inspection at the Janssen vaccine manufacturing facility in Incheon, South Korea.

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Detailed Comments on Protocol Deviations Draft Guide

Labcorp and AstraZeneca submit line-by-line comments on an FDA draft guidance on clinical investigation protocol deviations.