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Human Drugs

FDA Regulatory Pathway Needed for Dementia Vaccine Trials: Opinion

An opinion article calls on FDA to establish a formal regulatory framework for evaluating vaccines as potential interventions to prevent dementia, arg...

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Human Drugs

Merck Wins Expanded Indication for Pneumococcal Vaccine

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

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Biologics

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

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

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Human Drugs

FDA Approves 1st Generic Version of Flu Drug Xofluza

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

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Biologics

Expand Some Islet Cell Transplantation Access: Senators

Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type 1 diabetes patients...

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Medical Devices

Data from First 100 QMSR Inspections Analyzed

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

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Human Drugs

Guide on Immunogenicity Data Submissions for Pharmacokinetic Reviews

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

Biologics

Senator Seeks FDA Records on Covid Vaccine Safety Review

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

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Biologics

Committee Backs Moderna Flu Vaccine

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

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Human Drugs

FDA Wants Testosterone Therapy Labels Updated

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