Approvals
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.
FDA greenlit Janssen’s Invega Hafyera, the first long-acting antipsychotic drug of its kind that provides six months’ control of symptoms with a single dose.
Mesoblast shares dropped on the last day of August 2021 after it was told that its candidate COVID-19 treatment needs to undergo another trial to be green-lit for emergency approval by the FDA.
FDA approved Ascendis Pharma’s Skytrofa for children one year and older who have growth failure from inadequate secretion of endogenous growth hormone.
Less than 10 days after the FDA slammed Sesen bladder cancer drug with a CRL, the company has withdrawn its Marketing Application Authorization from the European Union.
PRESS RELEASES