The FDA has given the green light to Omisirge (omidubicel-onlv), an allogeneic cell therapy derived from modified cord blood, which aims to accelerate the recovery of neutrophils and lower the risk of infection in patients with blood cancers. The treatment is designed for adults and children aged 12 and above ...
Read More »Former FDA Official Warns Lawmakers, U.S. Baby Formula Supply is Still Vulnerable
On Tuesday, a former official from the Food and Drug Administration (FDA) informed U.S. lawmakers that over a year since a nationwide shortage that caused distress to parents trying to feed their children, the infant formula supply in the United States remains vulnerable to safety issues and supply disruptions. During ...
Read More »FDA approves Auvelity to treat major depressive disorder
The US Food and Drug Administration (FDA) has approved Axsome Therapeutics Auvelity (dextromethorphan and bupropion) for the treatment of adult patients with major depressive disorder. Auvelity is claimed to be the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist with multimodal activity approved for the treatment of the major ...
Read More »FDA to Off Juul e-cigarettes from US markets
The US Food and Drug Administration is set to remove Juul Lab e-cigarettes from the US market. Sources told The Wall Street Journal that the decision could come as early as Wednesday after a two-year review of reams of data submitted by the vaping company. The FDA has already banned ...
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