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Human Drugs

FDA Warns Indias Granules Generic Drug Company

An Indian news service says FDA has sent a Warning Letter to drug manufacturer Granules following a 2024 inspection at the firms facility in Gagillapu...

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Medical Devices

Ventec Recalls VOCSN Ventilators

Ventec Life Systems recalls its VOCSN Multi-Function Ventilators because the devices were serviced using incorrect parts which can lead to device shut...

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Human Drugs

Makary FDA Confirmation Hearing Set for 3/6

The Senate Health Education Labor & Pensions committee sets a 3/6 confirmation hearing to review the nomination of Johns Hopkins surgeon and public po...

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Human Drugs

7 Observations in Zhejiang Huahai FDA-483

FDA releases the form FDA-483 with seven observations from an inspection at Chinas Zhejiang Huahai API manufacturing facility.

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Human Drugs

6 Observations on Piramal Pharma FDA-483

FDA releases the form FDA-483 with six observations from an inspection at Indias Piramal Pharma API manufacturing facility.

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Human Drugs

Indoco Remedies FDA-483 Released

FDA releases the form FDA-483 with seven observations from an inspection at Indias Indoco Remedies manufacturing facility for sterile and non-sterile ...

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Human Drugs

Camizestrant in Breast Cancer Meets Primary Endpoint

Data from an AstraZeneca interim analysis of its SERENA-6 Phase 3 breast cancer trial show that camizestrant in combination with a cyclin-dependent ki...

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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.