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Wristband that provides relief for upper limb tremor is approved; FDA warns of clinically significant weight loss in younger kids taking ADHD meds; REMS removed for CAR T-cell immunotherapies; ...
Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.
The approval was supported by pooled data from 2 open-label, single arm trials: the phase 2 NI-0501-06 study and the phase 3 EMERALD trial.
The wearable, transcutaneous neurostimulation device delivers personalized therapy using a proprietary AI algorithm.
The Food and Drug Administration (FDA) has granted accelerated approval to Lynozyfic™ (linvoseltamab-gcpt) for the treatment of adult patients with ...
An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination ...
“While the phase 3 results of GCAptAIN did not replicate the positive outcomes observed in the phase 2 trial, we remain committed to continuing to drive scientific progress and deepening the ...
The approval of sunvozertinib, an oral irreversible EGFR inhibitor, was supported by data from the WU-KONG1B trial (ClinicalTrials.gov Identifier: NCT03974022 ). The primary efficacy population ...
The decision came Tuesday from US District Judge Melissa DuBose in response to a lawsuit filed by attorneys general from 19 states and the District of Columbia, the Associated Press reported. DuBose ...
HealthDay News — Attention-deficit/hyperactivity disorder (ADHD) medications remain associated with a reduced risk for various real-world outcomes, but the magnitude of these associations decreases ...
The Food and Drug Administration (FDA) has approved Tyzavan ™ (vancomycin injection, USP), a novel ready-to-infuse, room temperature stable formulation of vancomycin, for the treatment of various ...
We spoke with Dr Kellan Baker of the Whitman-Walker institute to shed some light on the many changes taking place to various aspects of medical care for LGBTQ+ individuals.
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