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FDA Has No Plans to Pull Abortion Pill: Makary

[ Price : $8.95]

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...

Staff Cuts Lead to Drug Data Gaps: Sources

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Axios reports that key FDA databases that are relied on by healthcare professionals are not being fully updated due to staff short...

FDA OKs Akesos Nasopharyngeal Cancer Therapy

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FDA approves an Akeso Biopharma BLA for penpulimab-kcqx, indicated for adults with recurrent or metastatic non-keratinizing nasoph...

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...

Cobenfy Effective as Schizophrenia Adjunct: Trial

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Bristol Myers Squib says its Cobenfy showed positive results in the Phase 3 ARISE trial as an adjunctive therapy to atypical antip...

Update Drug Labels with Obesity Info: Pitts

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Former FDA associate commissioner Peter Pitts calls on the agency to revise drug labels with obesity safety and effectiveness info...

Lilly Sues 4 More Weight-Loss Drug Compounders

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Lilly sues four additional drug compounders for illegally selling copies of its weight loss and diabetes drugs.

Alert Issued on Conavis Novasight Catheters

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The catheter is part of a system intended for intravascular imaging of coronary arteries.

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.