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Bone, Reproductive/Urologic Drugs Panel Renewed

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Federal Register notice: FDA announces the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an addition...

Lexicon Pharma Fast Track for Neuropathic Pain

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FDA grants Lexicon Pharmaceuticals a fast track designation for LX9211 and its use in treating diabetic peripheral neuropathic pai...

Sanofi/GSK Delay Covid Vaccine Over Disappointing Data

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Sanofi and GlaxoSmithKline delay their Covid-19 vaccine program to improve immune response in older adults.

Covid-19 Vaccine EUA Granted Amid White House Pressure

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FDA grants an emergency use authorization for Pfizer-BioNTechs Covid-19 vaccine amid a White House threat for commissioner Stephen...

ReCor Medical Breakthrough for Hypertension Device

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FDA grants ReCor Medical a breakthrough device designation for Paradise Ultrasound Renal Denervation System and its use for treati...

3 New Device Guides for Performance-Based Pathway

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FDA posts three new guidances for device makers to use under its Safety and Performance-Based Pathway.

X4 Pharma Gets Rare Pediatric Disease Status

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FDA grants X4 Pharmaceuticals a rare pediatric disease designation for mavorixafor for treating WHIM (Warts, Hypogammaglobulinemia...

FDA Accepts Atox Bio NDA Filing for Reltecimod

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FDA accepts for filing an Atox Bio NDA for reltecimod to treat patients with necrotizing soft tissue infections.

Researchers Find No Excess Deaths in Paclitaxel-Coated Devices

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Swedish researchers say they found no significant increase in the risk of death in patients who received paclitaxel-coated devices...

FDA Withdrawing Approval of Allergans Asacol

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Federal Register notice: FDA withdraws the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delay...