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May 10, 2023
On April 5, 2023, the U.S. Food and Drug Administration ("FDA") announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection ("Makena"...
April 27, 2023
U.S. Food and Drug Administration FDA announced decision to withdraw approval of Makena® hydroxyprogesterone caproate injection, drug approved in 2011 to reduce risk of preterm birth in certain pregnant women.
April 27, 2023
On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug...
April 26, 2023
On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle...
April 21, 2023
On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle...
March 28, 2023
The FDA has issued draft guidance to improve applications for accelerated approvals, according to a recently issued news release.
March 24, 2023
/PRNewswire/ -- Today, the U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology...
October 29, 2021
The FDAs oncology division has made it easier to check on how much evidence supports the use of drugs cleared for sale via an accelerated approval.