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AstraZeneca Can Export Vaccine Made at Emergent Bio: FDA

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CBER says AstraZeneca can export three lots of Covid-19 vaccine drug substance manufactured at Emergent BioSolutions troubled cont...

Pfizer/BioNTech Booster Data Submitted to FDA

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Pfizer and BioNTech submit Phase 1 data to FDA to support the evaluation of a booster dose of their Covid-19 vaccine.

Studies Confirm Boston Scientifics Mesh Withdrawal

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Two Boston Scientific post-market surveillance studies confirm the unfavorable benefit-risk profile of now-withdrawn Boston Scient...

Thermo Fisher Gets 2 EUAs for Covid Tests

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FDA grants Thermo Fisher Scientific emergency use authorizations for the TaqPath Covid-19 Fast PCR Combo Kit 2.0 and the TaqPath C...

Lillys Lyumjev OKd for Insulin Pump

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FDA approves Eli Lillys rapid-acting insulin Lyumjev (insulin lispro-aabc injection) 100 units/mL for administration by continuous...

Former FDA Head Hahn Urges FDA Independence

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Former Trump administration FDA commissioner Stephen Hahn urges more independence for the agency to prevent political interference...

CDERs Ellis Unger Retiring After 24 Years at Agency

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CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger retires to spend more time with family.

Drug User Fee Rates for FY 2022

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Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2022.

Pfizer, Moderna Booster Authorized for Immunocompromised

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FDA amends the emergency use authorizations for both Pfizer-BioNTechs and Modernas Covid-19 vaccines to allow for the use of an ad...

Ipsen Withdraws NDA Palovarotene for More Analyses

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Ipsen withdraws its NDA palovarotene, indicated for preventing heterotropic ossification as a potential treatment for people livin...