Regulatory
Cortexyme said it plans to provide additional updates pending further talks with the FDA.
Incyte’s decision follows consultation with the FDA, where it decided that it could not support any confirmatory studies that might be required in the future given the limited time frame.
The FDA placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected adverse events.
Much has been made about the side effects of the COVID-19 vaccines, but a new study found a startlingly high number of adverse events associated with people who received placebos in clinical trials.
Shares of Mustang Bio have fallen more than 13% in premarket trading after announcing the FDA had placed a hold on the company’s Investigational New Drug application for its bubble boy gene therapy.
As Omicron continues to dominate globally, research is coming in every day on this highly contagious variant of SARS-CoV-2.
The company submitted its application for AP-188 in early 2021, covering dosage details, formulation, and method of stroke rehabilitation.
Oncopeptides has discontinued the marketing of Pepaxto drug in the US. But, in a recent turnaround, they decided to withdraw this decision of stopping the production.
The U.S. Food and Drug Administration issued a Complete Response Letter to Merck & Co. for its New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough.
FDA rejected OPKO’s once-weekly human growth hormone, somatrogon, which it co-developed with Pfizer for the treatment of growth hormone deficiency (GHD) in pediatric patients.
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