FDA
The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while examining several endpoints, simultaneously.
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Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
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The amended EUA is aimed at patients who have undergone solid organ transplants or those diagnosed with conditions that have an “equivalent level of immunocompromised.”
This approval was based on the Phase III withdrawal study that showed clinically meaningful differences vs. placebo in change to the primary endpoint, Epworth Sleepiness Scale score.
The U.S. FDA greenlit the combination of Keytruda and Eisai’s Lemvima as a first-line treatment for adult patients with advanced renal cell carcinoma.
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.
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.
Eisai said that they have initiated communication with the FDA to achieve “the most optimal regulatory pathway” for lecanemab.
Sage announced the termination of the REDWOOD and RAINFOREST studies of zuranolone, which is being assessed to treat both major depressive disorder and post-partum depression.
The FDA’s Treosulfan rejection was surprising for both Meduxus and Medac. The FDA has provided a Complete Response Letter and made some recommendations.