Regulatory
Not everyone is so confident that Aduhelm will transform the Alzheimer’s drug development landscape.
Despite controversy over the drug’s effectiveness, it appears to have spiked interest in investing in Alzheimer’s drug companies, something that had been on the decline for several years.
June is turning out to be a busy month for PDUFA dates for the U.S. Food and Drug Administration. Here’s a look at this week’s dates.
Calliditas is developing Nefecon, a down regulator of IgA1 and proprietary, novel oral formulation of budesonide – a potent and established immunosuppressant – for the treatment of IgAN.
Inclusions and treatment initiation will be paused in all ongoing clinical studies until an investigation into the potential safety issue is complete.
The FDA gave the green light to Amgen’s Lumakras under accelerated approval as a treatment for patients with KRAS mutation whose disease has worsened over time.
The U.S. FDA is starting off the summer months with a busy week after the Memorial Day holiday in the U.S. Here’s a look.
The question before the committee was whether the benefits of teplizumab outweigh the risks as it voted 10-7 in favor of the drug to delay clinical type 1 diabetes mellitus.
The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
To develop and commercialize them with maximum efficiency, the FDA, scientists and developers must innovate, according to panelists speaking during the Presidential Plenary on Commercialization at the International Society of Cell & Gene Therapy on May 26.
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