H5N1 bird flu virus particles found in pasteurized milk, but FDA says commercial milk supplies appear safe

H5N1 bird flu virus particles found in pasteurized milk, but FDA says commercial milk supplies appear safe

wattAshton The U.S. Food and Drug Administration confirmed Tuesday that agency testing of commercially purchased pasteurized milk found genetic evidence of the H5N1 avian influenza virus. But tests using the …

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Clinicians slam FDA for approving opioid addiction test

Clinicians slam FDA for approving opioid addiction test

A group of researchers has urged U.S. regulators to withdraw approval of a test used to predict the risk of opioid addiction, saying government health programs should not pay for …

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Oncologists defend CAR-T after FDA recommendation BioSpace

Oncologists defend CAR-T after FDA recommendation BioSpace

Pictured: Cell Therapy Concept/iStock, Meletios Verras Last month, the FDA announced it was reviewing BCMA- or CD19-directed autologous CAR T-cell therapies after receiving reports of secondary blood cancers in patients …

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Ocugen receives unanimous FDA approval on key aspects of pivotal Phase 3 study design for OCU400 modified gene therapy

Ocugen receives unanimous FDA approval on key aspects of pivotal Phase 3 study design for OCU400 modified gene therapy

Okugan MALVERN, Pa., Dec. 21, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN) is a biotechnology company focused on the discovery, development and commercialization of novel …

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4DMT’s 4D-150 gene drug for the intravitreal treatment of wet AMD received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, the first RMAT designation for wet AMD

4DMT’s 4D-150 gene drug for the intravitreal treatment of wet AMD received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, the first RMAT designation for wet AMD

4D Molecular Therapeutics Inc. The designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and clinical activity profile in patients with wet age-related …

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