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FDA Refuses to File Nymox Pharma NDA
[171 Words]
[ Price : $8.95]
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| FDA sends Nymox Pharmaceutical a Refusal to File letter for its NDA for fexapotide triflutate for treating benign prostatic hyperplasia, requesting long-term safety data. |
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05/24/2022
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CSL Behring BLA for Hemophilia B Gene Therapy
[243 Words]
[ Price : $8.95]
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| FDA accepts for priority review a CSL Behring BLA for etranacogene dezaparvovec, an investigational gene therapy for treating adults with hemophilia B. |
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05/24/2022
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Revoke Children’s Covid Vaccine EUA: ICAN
[2795 Words]
[ Price : $8.95]
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| The Informed Consent Action Network says FDA should revoke the EUA for Pfizer’s Covid vaccine in children ages 12-15 and not approve an EUA for Moderna’s vaccine for youths ages 12-17. |
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05/24/2022
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Groups Want Stronger Post-Market Trial Enforcement
[2722 Words]
[ Price : $8.95]
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| U.S. PIRG and other advocacy groups urge that stricter enforcement of post-market clinical trials for accelerated approval drugs be included in FDA user fee reauthorization. |
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05/24/2022
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Antibacterial Therapy Q&A Guidance
[2733 Words]
[ Price : $8.95]
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| FDA publishes a draft guidance with questions and answers on developing antibacterial therapies for patients with an unmet medical need to treat serious bacterial diseases. |
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05/24/2022
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Vanda Sues FDA to Overturn Fast Track Rejection
[2909 Words]
[ Price : $8.95]
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| Vanda Pharmaceuticals asks the DC federal court to set aside an FDA determination that the company’s tradipitant does not qualify for a fast track designation. |
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05/24/2022
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INmune Bio Clinical Hold on TNF Therapy
[116 Words]
[ Price : $8.95]
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| FDA places a clinical hold on an INmune Bio Phase 2 trial for XPro 1595, a next-generation inhibitor of tumor necrosis factor (TNF) that is designed to neutralize soluble TNF, without affecting trans-membrane TNF or TNF receptors. |
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05/24/2022
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Aurobindo Pharma FDA-483
[2759 Words]
[ Price : $8.95]
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| FDA releases the FDA-483 with six observations from an inspection at India’s Aurobindo Pharma drug manufacturing facility. |
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05/24/2022
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