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FDA Regulatory Pathway Needed for Dementia Vaccine Trials: Opinion

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An opinion article calls on FDA to establish a formal regulatory framework for evaluating vaccines as potential interventions to p...

Merck Wins Expanded Indication for Pneumococcal Vaccine

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Merck says FDA has approved an expanded indication for its pneumococcal conjugate vaccine, Capvaxive, allowing its use in children...

Beam Gets OK to Begin Clinical Testing of PKU Gene-Editing Therapy

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FDA approves a Beam Therapeutics IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing...

FDA Approves 1st Generic Version of Flu Drug Xofluza

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FDA approves the first generic version of Xofluza (baloxavir marboxil), clearing Norwich Pharmaceuticals' generic tablets for the ...

Expand Some Islet Cell Transplantation Access: Senators

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Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type...

Data from First 100 QMSR Inspections Analyzed

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Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new ...

Guide on Immunogenicity Data Submissions for Pharmacokinetic Reviews

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FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immu...

Senator Seeks FDA Records on Covid Vaccine Safety Review

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Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from...

Committee Backs Moderna Flu Vaccine

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The FDA Vaccines and Related Biological Products Advisory Committee votes to support Moderns mRNA flu vaccine mFlusiva.

FDA Wants Testosterone Therapy Labels Updated

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HHS says FDA is seeking labeling changes for testosterone replacement therapy products to reflect current scientific and clinical ...