Regulatory
The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria.
The month of June continues to be busy for the U.S. Food and Drug Administration. There are three PDUFA dates on the calendar for this week. Here’s a look.
The $7 billion transaction by Datavant with Ciox Health will be the nation’s largest “neutral and secure health data ecosystem.”
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.
PRESS RELEASES