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Novo Nordisk Resubmits BLA for Once-Weekly Insulin

[ Price : $8.95]

Novo Nordisk refiles its BLA for Awiqli (insulin icodec), a once-weekly basal insulin injection for adults with Type 2 diabetes.

FDA Tells IO Biotech to Delay Cancer Vaccine Filing

[ Price : $8.95]

FDA tells IO Biotech not to submit a BLA for its experimental cancer vaccine Cylembio based on results from a recently completed P...

FDA Expands Device Early Alert Program

[ Price : $8.95]

FDA expands its medical device Early Alert program to cover all products that may pose significant safety risks.

FDA Presses for Clinical Trial Reporting Compliance

[ Price : $8.95]

CDER director George Tidmarsh urges more compliance with clinical trial reporting requirements through the Clinicaltrials.gov gate...

AbbVie Files NDA for Parkinsons Drug Tavapadon

[ Price : $8.95]

AbbVie files an NDA for tavapadon, an investigational once-daily oral therapy for Parkinsons disease.

Eyeglass Lenses OK'd for Pediatric Nearsightedness

[ Price : $8.95]

FDA grants Essilor a de novo marketing authorization for its Stellest eyeglass lenses, which are designed to both correct vision a...

FDA Approves New Drug for Acromegaly

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FDA approves a Crinetics NDA for Palsonify (paltusotine) for treating adults with acromegaly who have had an inadequate response t...

FDA Rebukes Novartis Over Misleading TV Ad

[ Price : $8.95]

FDA sends Novartis Pharmaceuticals an untitled letter citing the companys allegedly false or misleading direct-to-consumer televis...

Kennedy, Makary Pledge Mifepristone Review

[ Price : $8.95]

HHS secretary Robert F. Kennedy, Jr., says FDA is reviewing safety evidence relating to the medication abortion drug mifepristone.

FDA Ends Caprelsa REMS

[ Price : $8.95]

FDA says the Risk Evaluation and Management Strategy program that has been in place since 2011 for Sanofis thyroid cancer drug Cap...