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Review Period for Novo Nordisks Ozempic

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novo Nordisks Ozempic.

Merck sBLA Accepted for Keytruda in Bladder Cancer

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FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), Mercks anti-PD-1 therapy as monotherapy for...

Lexicon Loses Appeal of FDA Complete Response

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FDAs Office of New Drugs denies a Lexicon Pharmaceuticals appeal of a March Complete Response Letter on its NDA for diabetes drug ...

Former FDA Commissioner Frank Young Dies at 88

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Former FDA commissioner Frank Young dies at age 88.

Tzvi Lexiere Debarred for 10 Years

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Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for co...

Six ANDAs Withdrawn by FDA

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FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer ...

Draft Guide on Biosimilar Clinical Immunogenicity

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Federal Register notice: FDA makes available a draft guidance entitled Clinical Immunogenicity Considerations for Biosimilar and I...

FDA Approves QuantiFeron-TB Plus Diagnostic

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FDA approves a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus, a fourth-generation test for latent tub...

Zebra Medical 510(k) Cleared for HealthCXR

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FDA clears a Zebra Medical Vision 510(k) for its HealthCXR device intended for use in identifying and triaging pleural effusion in...

B. Braun Recalls Blood Administration Sets

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FDA says B. Braun is recalling 43,026 blood administration sets that may leak at the joint between blood filters and tubing.