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BrainChild Breakthrough Status for Brain Tumor Therapy

[ Price : $8.95]

FDA awards BrainChild Bio a breakthrough therapy designation for its investigational CAR T-cell therapy, BCB-276, for treating a r...

Amneal Recalls Ropivacaine Hydrochloride Injection

[ Price : $8.95]

Amneal Pharmaceutical recalls two lots of ropivacaine hydrochloride injection USP, 500 mg/100 mL, infusion bags because the produc...

FDA Alert on False Positive Lead Tests

[ Price : $8.95]

FDA alerts health care providers about reports of falsely elevated results associated with ASP Globals RAM Scientific SAFE-T-FILL ...

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

[ Price : $8.95]

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

[ 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

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Seeks Post-Marketing Commitment from Novavax

[ Price : $8.95]

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