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FDA Suddenly Cancels Crucial Flu Vaccine Meeting

[ Price : $8.95]

In a move linked to HHS secretary Robert F. Kennedy Jr., FDA suddenly cancels a 3/13-planned Vaccines and Related Biological Produ...

Fast-Track for Adicet Systemic Sclerosis Drug

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FDA grants fast-track designation for Adicet Bios ADT-001 to treat systemic sclerosis.

19-Page Exela Pharma Sciences FDA-483

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FDA releases the 19-page form FDA-483 with 15 observations from an inspection at the Exela Pharma Sciences outsourcing facility in...

FDA Clears Visby Respiratory Health Test

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FDA clears a Visby Medical 510(k) for its point-of-care test for detecting respiratory infections caused by influenza A & B, and C...

7 Observations in Zhejiang Huahai FDA-483

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

6 Observations on Piramal Pharma FDA-483

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

Indoco Remedies FDA-483 Released

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

Camizestrant in Breast Cancer Meets Primary Endpoint

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

Google Watch Cleared for Pulse Loss Detection

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

CDER Touts FY 2024 Drug Safety Activities

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