FDA grants accelerated approval to Forzinity for Barth syndrome
The FDA approved elamipretide (Forzinity) on September 19, 2025, for adults and children with Barth syndrome who weigh at least 30 kg.
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HISTORICAL UPDATES
The regulatory archive.
Historical reporting with original publication dates preserved and source links included.
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FDA approves oral Wegovy semaglutide pill for weight management
The FDA approved once-daily oral semaglutide tablets under the Wegovy brand on December 22, 2025. Here is what the announcement means.
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FDA approves Wegovy HD 7.2 mg semaglutide injection
On March 19, 2026, the FDA approved a higher-dose Wegovy injection for certain adults with obesity. Approval and label details.
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FDA publishes 17 revised draft guidances for generic peptide medicines
The July 28, 2026 draft guidances describe FDA recommendations for generic peptide drug development. They are guidance, not product approvals.
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FDA takes a policy step on compounding certain peptides
An October 2026 FDA policy development concerns compounding restrictions. The step is not approval of the peptides under discussion.
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