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FDA Panel: Tolerating Approval Outliers Would Set ‘Dangerous Precedent’

An unprecedented wait for final FDA approval will drag on for two orphan lymphoma drugs, at least a little while longer, as the agency decides how to end the delays and prevent them from happening again. The dihydrofolate reductase inhibitor pralatrexate (Folotyn) received accelerated approval in 2009 and the histone deacetylase (HDAC) inhibitor belinostat (Beleodaq) […]

CATIS-2: Delayed Antihypertension Tx for Acute Ischemic Stroke Still an Option

DALLAS — Antihypertensive treatment could wait for 7 days following an acute ischemic stroke (AIS), so long as the patient has no comorbidities that warrant the emergency reduction of their blood pressure (BP). In the CATIS-2 trial, there was no significant difference in the composite of major disability and death between patients with AIS who […]

Patient Accused of HIPAA Violation, Threatened With Jail for TikTok Posts

A confrontation between hospital staff and a patient over wait times and patient rights was documented in a series of viral TikTok videos, according to a local news report. Denise Bradley, a patient at Beaumont Hospital in Dearborn, Michigan, was confronted by hospital security and a nurse after she was found to be recording an […]

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