Pipeline Preview for August
FDA Sets Goal Date for Cardiomyopathy Drug, Aficamten
The FDA has accepted a new drug application for aficamten, a new obstructive hypertrophic cardiomyopathy drug. A goal date has been set for Sept. 26, 2025.
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Sixth Stelara Biosimilar, Yesintek, FDA-Approved
Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.
Johnson and Johnson Submits FDA Request for Pediatric Tremfya Approval
If granted, Tremfya will be approved to treat children ages six and under with severe plaque psoriasis and children ages five and under with juvenile psoriatic arthritis.
FDA Accepts sNDA ATTR Amyloidosis Drug, Vutrisiran
Vutrisiran is the generic form of previously approved Amvuttra. The FDA’s target date for the treatment of transthyretin amyloidosis with cardiomyopathy is March 23, 2025.
Biden Proposes Rule to Allow Medicare, Medicaid to Cover Antiobesity Drugs
Whether this proposed rule actually has any impact remains to be seen, especially with a new administration led by Donald Trump’s new health appointees.
FDA Approves New Imatinib Oral Solution
Imkeldi is a new formulation of imatinib approved as a strawberry-flavored, shelf-stable liquid designed to be more appealing to a wider range of patients, pediatric patients included.
