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Multiple Violations at Empower Pharma

[ Price : $8.95]

FDA warns Houston, TX-based Empower Pharma about multiple violations in its production of unapproved and misbranded compounded dru...

Norwich Loses Generic Rifaximin Case

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The DC federal court throws out Norwichs suit seeking to force FDA to find that Actavis has forfeited its exclusivity for a generi...

FDA Has No Plans to Pull Abortion Pill: Makary

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FDA commissioner Martin Makary says there are no current plans to restrict access to the abortion drug mifepristone.

Abbott Recalls HeartMate Power Units

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Abbott recalls its HeartMate Mobile Power Unit to remove the component due to instances where the device experiences a sudden powe...

FDA Seeks Post-Marketing Commitment from Novavax

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Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.

CereVasc Gains Breakthrough Status for eShunt

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FDA grants CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating ...

ESG NextGen is Live: FDA

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FDA says its Electronic Submission Gateway Next Generation is live and ready to receive submissions.

Vanda Criticizes FDA on Tradipitant Hearing Delay

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Vanda Pharmaceuticals criticizes FDA for wrongly claiming that recent staff cuts and a new commissioner causes it to delay a compa...

Akesos Ivonescimab Meets Endpoint in Lung Cancer

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Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous n...

ASCO Reaches Out to FDA, NIH, CMS

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The Association for Clinical Oncology tells the new leaders of FDA, NIH, and CMS it looks forward to working with them on behalf o...