Food and Drug Administration (FDA)
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AbbVie’s Allergan Aesthetics announced it was buying Soliton in a deal worth about $550 million. Now, the Federal Trade Commission has requested additional information about the deal.
The hold is related to a report of a SUSAR of myelodysplastic syndrome in a patient treated with eli-cel, also known as Lenti-D, in a Phase III clinical trial.
Seagen forged an exclusive licensing agreement with China’s RemeGen Co., Ltd, to develop and commercialize disitamab vedotin, a novel HER2-targeted ADC.
Sanofi has announced that the U.S. FDA approved its new treatment for children one year of age or older diagnosed with late-onset Pompe disease.
As COVID-19 vaccines near full approval by the U.S. FDA, Dr. Anthony Fauci expects several organizations across the country, including businesses and schools, will issue their own vaccine mandates before people can enter their establishments.
The clinical study compared Enhertu to Kadcyla in HER2+ metastatic breast cancer patients who previously received trastuzumab.
Although August is a fairly busy month for PDUFA dates, there were only two on the U.S. FDA’s calendar for this week, and one of those has already been reported. Here’s a look.
Sierra will have access to AZD5153, a potent and selective BRD4 BET inhibitor, to initiate a study that combines the said component with momelotinib for treating patients with myelofibrosis.
Aprea faces another disappointment this week in the clinic. The FDA held up a yellow card, and the Boston-based biotech has placed a partial clinical hold on its myeloid malignancy program.
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