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FDA Seeks Warning on OTC Acetaminophen Products

[ Price : $8.95]

Federal Register notice: FDA announces a proposed administrative order to require a warning on Over-the-Counter Internal Analgesic...

Teleflex/Arrow Recall Aortic Catheters

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Teleflex and subsidiary Arrow International recall (Class 1) the Arrow FiberOptix Intra-Aortic Balloon Catheter Kits and Arrow Ul...

Getinge Recalls Vaporizer Sevoflurane Maquet Filling

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Getinge recalls (Class 1) its Vaporizer Sevoflurane Maquet Filling after receiving reports of discoloration or corrosion within th...

Novavax Amends Covid Vaccine EUA

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Novavax files an amendment to its Emergency Use Authorization for an updated JN.1 Covid-19 vaccine (NVX-CoV2705) for individuals a...

Guide on Diabetic Foot Infection Drugs

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FDA posts a final guidance entitled Diabetic Foot Infections (DFI): Developing Drugs for Treatment.

Amgens Blincyto Gets Expanded Leukemia Use

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FDA approves an expanded use for Amgens Blincyto (blinatumomab) for treating adult and pediatric patients one month or older with ...

3 Bayesian Examples Added to Demonstration Project

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FDA adds three Bayesian statistical analysis examples to the CDER Center for Clinical Trial Innovation Web page.

Supreme Court Rejects Mifepristone Lawsuit

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The U.S. Supreme Court 6/13 unanimously rejects a lawsuit seeking to sharply restrict distribution of the chemical abortion pill m...

FDA Revises Covid Vaccine Composition Recommendation

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FDA updates its advice on this falls Covid-19 vaccine composition based on a recent review of circulating Covid cases in the U.S.

Pfizer Duchene Gene Therapy Fails Phase 3 Study

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Pfizer says that its Phase 3 CIFFREO placebo-controlled study evaluating an investigational mini-dystrophin gene therapy, fordadis...