Food and Drug Administration (FDA)
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Clinical data showed Dupixent reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids.
AstraZeneca recently reported positive interim data from clinical trials of two, and potentially a third, of its drugs for cancer.
According to the poll results, 78% of respondents agree that the high costs of a gene therapy treatment are worth it, due to the fact that these options are seen as potential cures for disease.
The Complete Response Letter indicated the company will need to run an “adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS.”
The partial clinical hold was lifted after the company revised the study protocol for the trial. The partial clinical hold remains on other multiple myeloma trials involving venetoclax.
Glenmark said it should be able to resolve the FDA’s concerns within six to nine weeks and will work with the regulatory agency toward approval.
July looks to be a quiet month for the U.S. Food and Drug Administration (FDA), and it sure looks like the agency is trying to get a lot of work done before the July 4 holiday. Here’s a look at the many approvals scheduled for this week.
The regulatory agency is establishing new standards for the approval of opioid medications.
The U.S. Food and Drug Administration (FDA)’s Circulatory System Devices Panel is in the middle of two days of presentations and meetings regarding mortality rates associated with the use of paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs). The discussions are noting missing data and conflicting analysis.
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