Approvals
FDA external advisors will meet to consider Pfizer and BioNTech data in support of booster shots. The two companies also expect to file for Vaccine Authorization for children in the coming months.
The FDA awarded a number of designations for Takeda’s candidate drug EXKIVITY in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.
FDA has been actively greenlighting a number of efforts over the last few days to push therapies for rare or serious diseases that have largely unmet medical needs. Here’s a look.
Brukinsa was approved for MSL patients who have received at least one anti-CD20-based regimen.
A recent study suggests that about one-third of cancer indications with Accelerated Approval pathways are still on product labels without follow-up studies confirming their benefits.
September is turning out to be a busy month for the U.S. Food and Drug Administration. Here’s a look at this week’s schedule for PDUFA dates.
The FDA stated that it could not determine if the use of lenzilumab in COVID patients outweighs the known and potential safety risks.
Sometimes the U.S. Food and Drug Administration (FDA) runs ahead of schedule. In the case of this week’s two PDUFA dates, that was completely true. Here’s a look.
There were a fair number of clinical trial announcements last week. Here’s a look.
The approval was built on data from the Phase III ASPEN trial that compared Brukinsa to ibrutinib in a total of 201 patients. Here’s more about the drug.
PRESS RELEASES