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TXT FDA Refuses to File Nymox Pharma NDA [171 Words] [ Price : $8.95]
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.
05/24/2022
 
 
TXT CSL Behring BLA for Hemophilia B Gene Therapy [243 Words] [ Price : $8.95]
FDA accepts for priority review a CSL Behring BLA for etranacogene dezaparvovec, an investigational gene therapy for treating adults with hemophilia B.
05/24/2022
 
 
TXT Revoke Children’s Covid Vaccine EUA: ICAN [2795 Words] [ Price : $8.95]
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.
05/24/2022
 
 
TXT Santhigram Kerala Selling Unapproved Drugs: FDA [2680 Words] [ Price : $8.95]
FDA cautions Santhigram Kerala Ayurvedic Co. of U.S. that it is marketing unapproved new drugs, including two it says will treat Covid-19.
05/24/2022
 
 
TXT Groups Want Stronger Post-Market Trial Enforcement [2722 Words] [ Price : $8.95]
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.
05/24/2022
 
 
TXT Antibacterial Therapy Q&A Guidance [2733 Words] [ Price : $8.95]
FDA publishes a draft guidance with questions and answers on developing antibacterial therapies for patients with an unmet medical need to treat serious bacterial diseases.
05/24/2022
 
 
TXT Vanda Sues FDA to Overturn Fast Track Rejection [2909 Words] [ Price : $8.95]
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.
05/24/2022
 
 
TXT RapidAI Pulmonary Embolism Identifier Cleared [121 Words] [ Price : $8.95]
FDA clears a RapidAI 510(k) for its Rapid PE Triage & Notification product for identifying a suspected central pulmonary embolism.
05/24/2022
 
 
TXT INmune Bio Clinical Hold on TNF Therapy [116 Words] [ Price : $8.95]
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.
05/24/2022
 
 
TXT Aurobindo Pharma FDA-483 [2759 Words] [ Price : $8.95]
FDA releases the FDA-483 with six observations from an inspection at India’s Aurobindo Pharma drug manufacturing facility.
05/24/2022
 
 
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