Shares of Foghorn Therapeutics were falling rapidly in premarket trading Tuesday after the company announced the FDA placed a full clinical hold on a Phase I dose escalation study. The trial had already been subject to a partial hold following a patient death.
Tag Archive for: U.S. Food and Drug Administration (FDA)
The U.S. Centers for Disease Control and Prevention (CDC) on Monday signed off on the use of Novavax Inc.’s COVID-19 vaccine for adolescents aged 12 through 17.
The U.S. Food and Drug Administration (FDA) has asked Pfizer Inc. to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday.
The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for this indication.
South Korea-based Genuv Inc. announced the publication of a preclinical study showing that Mekinist (trametinib), approved by the FDA for melanoma, has a neuroprotective effect in Alzheimer’s disease.
The U.S. Food and Drug Administration on Wednesday approved bluebird bio’s gene therapy for patients with a rare disorder requiring regular blood transfusions, and the drugmaker priced it at a record $2.8 million.
The U.S. Food and Drug Administration (FDA) adopted a final rule on Tuesday to create a new category of over-the-counter hearing aids that can be sold directly to millions of Americans.
Tuesday morning saw the FDA acceptance of a supplemental New Drug Application (sNDA) and supplemental Biologics License Application (sBLA) for three industry powerhouses.
Inhibrx Inc. announced that the European Commission (“EC”), based on a positive opinion issued by the European Medicines Agency (“EMA”), has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma.
Novavax Inc. said on Monday it had filed for U.S. authorization for use of its COVID-19 vaccine as a booster dose in people who had either received its shots or a different vaccine.
