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FDA Panel to Review 2 RSV Vaccines

[ Price : $8.95]

Federal Register notice: FDA announces a 2/28 to 3/1 Vaccines and Related Biological Products Advisory Committee meeting to discus...

No Justification for Lexicon Hearing: CDER

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CDER says Lexicon has failed to justify its request for an agency hearing on the Centers refusal to approve the companys NDA for s...

CDER Planning 98 New, Revised Guidances for 2023

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CDER releases its proposed 2023 guidance agenda showing 98 planned new and revised guidances in 18 categories.

Lyme Disease Drug Development Guidance

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FDA publishes a draft guidance with recommendations about developing drugs for treating early Lyme disease as manifested by erythe...

IBSA Recalls Some Tirosint-Sol Lots

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FDA says IBSA Pharma is recalling 27 lots of Tirosint-Sol oral solution due to subpotency.

NCTR Science Panel to Provide Update

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Federal Register notice: FDA announces a 4/4-5 advisory committee meeting of the Science Advisory Board to the National Center for...

Pfizer Gains Expanded Ibrance Indication

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Pfizer says it gained an expanded indication in late December for Ibrance (palbociclib) to include its use in combination with an ...

Clarius Mobiles Musculoskeletal AI Measurer

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FDA clears a Clarius Mobile Health 510(k) for its new MSK (musculoskeletal) AI model, which automatically identifies and measures ...

Xenex Files De Novo for Disinfection Device

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Xenex Disinfection Services files a de novo petition for its LightStrike+ ultraviolet room disinfection technology.

RightEye Promoting Off-Label Use: FDA

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FDA warns Bethesda, MD-based RightEye that it is promoting off-label use of its adulterated and misbranded RightEye Vision System.