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TXT Notice Corrected on Donor Eligibility Requirements [81 Words] [ Price : $8.95]
Federal Register notice: FDA corrects a 5/24 notice on a draft guidance being made available entitled "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy” due to an incorrect comment period due date.
06/13/2022
 
 
TXT Pfizer, Moderna Vaccines Safe & Effective in Children: FDA [273 Words] [ Price : $8.95]
As FDA prepares for a 6/14-15 advisory committee meeting on pediatric Covid-19 vaccines, agency briefing documents find the Pfizer-BioNTech and Moderna Covid-19 vaccines are safe and effective in children aged six years and younger.
06/13/2022
 
 
TXT Comments Extended on Antimicrobial Drug Use [75 Words] [ Price : $8.95]
Federal Register notice: FDA extends the comment period for a 2/16 notice that requested comments on antimicrobial drug use practices in companion animals and impacts on antimicrobial resistance.
06/13/2022
 
 
TXT FDA OK’s Cancer Drugs Faster/Sooner Than EMA: Study [2781 Words] [ Price : $8.95]
A new JAMA online study finds that FDA reviews and approves new oncology therapies much faster and sooner than the EMA.
06/13/2022
 
 
TXT Science Advisory Board Renewal [55 Words] [ Price : $8.95]
Federal Register notice: FDA renews its Science Advisory Board to the National Center for Toxicological Research for an additional two years.
06/13/2022
 
 
TXT FDA Hits Rentschler Biopharma with 9-item 483 [2640 Words] [ Price : $8.95]
A February inspection at Rentschler Biopharma’s German drug substance manufacturing plant results in a nine-item FDA-483 that cites significant GMP violations.
06/13/2022
 
 
TXT Health Canada OKs ALS Drug Delayed at FDA [371 Words] [ Price : $8.95]
While FDA extends its own NDA review, Health Canada approves Amylyx Pharmaceuticals Albrioza (sodium phenylbutyrate and ursodoxicoltaurine) for treating amyotrophic lateral sclerosis (Lou Gehrig’s Disease).
06/13/2022
 
 
TXT Ekso Bionics’ Exoskeleton Cleared for Multiple Sclerosis [2627 Words] [ Price : $8.95]
FDA clears an Ekso Bionics Holdings 510(k) to market its EksoNR robotic exoskeleton for use with multiple sclerosis patients.
06/13/2022
 
 
TXT Homology Clinical Hold on Gene Therapy Lifted [207 Words] [ Price : $8.95]
FDA removes a clinical hold on Homology Medicines and its pheNIX gene therapy clinical trial evaluating HMI-102 in adults with phenylketonuria after changes are made to clinical protocol.
06/13/2022
 
 
TXT Lilly’s Olumiant Approved for Alopecia [2839 Words] [ Price : $8.95]
FDA approves an Eli Lilly supplemental NDA for Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata.
06/13/2022
 
 
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