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FDA approves study into CAR-T associated cytokine storm

Drug Discovery World

The US Food and Drug Administration (FDA) has given the go-ahead to CytoAgents to initiate a US Phase Ib/IIa clinical trial investigating CTO1681 for cytokine release syndrome (CRS) in lymphoma patients receiving CAR-T cell therapy.

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FDA approves IND for clinical trial evaluating CBD-based drug

Outsourcing Pharma

The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

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Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

pharmaphorum

The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks. These examined Mounjaro in 5mg, 10mg and 15 mg doses in five clinical trials, used either as a stand-alone therapy or as an add-on to other diabetes medicines.

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FDA approves gene therapy for rare neurological disorder

Drug Discovery World

SKYSONA has become the first FDA approved therapy to slow the progression of neurologic dysfunction in boys with cerebral adrenoleukodystrophy (CALD). The post FDA approves gene therapy for rare neurological disorder appeared first on Drug Discovery World (DDW).

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

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Biohaven Eyes FDA Approval for Second Migraine Drug Zavegepant After Promising Trial Results

XTalks

Zavegepant has an advantage over the two as it’s the only CGRP receptor antagonist in both intranasal spray and oral pill formulations that is in clinical development for the treatment of acute or episodic migraines. The trial has enrolled over 1,400 adult participants with a history of migraines.

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Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19

The Pharma Data

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S. Source link: [link]