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Panel to Discuss Pfizer Booster Vaccine 9/17

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FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTechs supplemental ...

FDA Approves 6-Month Schizophrenia Drug

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FDA approves Janssens Invega Hafyera six-month atypical antipsychotic injection for some adult schizophrenia patients.

FDA Refusing to Approve ITCA 650

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FDA posts a Federal Register notice of its intent to not approve an Intarcia NDA for a diabetes drug/device combination product.

Info Collection on Device Establishment Fees

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Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device User Fee Cover Sheet, Form FD...

Drug Supply Security Info Collection

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Federal Register notice: FDA seeks comments on an information collection revision entitled Drug Supply Chain Security Act Implemen...

Omeza 510(k) for Collagen Wound Matrix

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FDA clears an Omeza 510(k) for its Omeza Collagen Matrix for chronic wound care.

Fraser Joins Greenberg Traurig

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Former FDA associate chief counsel for litigation James Fraser joins Greenberg Traurig.

Moderna Submits Covid Vaccine Booster Data to FDA

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Moderna submits trial data to FDA for an evaluation of its Covid vaccine booster shot.

House Chairs Want Aduhelm Info from FDA

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The chairs of two House committees ask FDA for detailed responses to 15 questions about the review and accelerated approval of Bio...

Takeda Reports Cancer Drugs Disappointing Trial Data

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Takeda Pharmaceutical reports disappointing data from its blood cancer Phase 3 PANTHER (Pevonedistat-3001) study, which did not ac...