FDA
FDA Issues Breakthrough Designations
The FDA granted several breakthrough device designations in September 2025 for innovative medical technologies. These designations expedite the development and review of devices addressing unmet needs. Updates include new approvals and predetermined change control plans.
FDA Grants Accelerated Approval for First Barth Syndrome Treatment
The U.S. Food and Drug Administration has granted accelerated approval to Forzinity, the first treatment for Barth syndrome, a rare X-linked genetic disorder primarily affecting males. Developed by Stealth Biotherapeutics, the therapy targets mitochondrial dysfunction underlying the condition, offering new hope for patients with this life-threatening disease. This milestone follows years of advocacy and highlights progress in addressing ultra-rare disorders.
Federal judge blocks expanded access to abortion pill mifepristone
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A federal judge in Texas has issued a ruling limiting the FDA's approval of mifepristone, the primary drug used in medication abortions. The decision revives a long-standing lawsuit challenging the drug's safety and regulatory process. This comes amid ongoing legal battles over abortion access following the Supreme Court's overturning of Roe v. Wade.
Coalition Opposes FDA's Proposed Ban on 7-OH Substance
A diverse group of organizations has publicly criticized the U.S. Food and Drug Administration's proposed ban on 7-Hydroxymitragynine (7-OH), arguing it threatens public health and ignores scientific evidence. The coalition, including health advocates and industry representatives, issued a joint statement on September 23, 2025, urging the FDA to reconsider. They claim the ban could limit access to potential therapeutic alternatives amid the ongoing opioid crisis.
FDA Approves Injectable Form of Merck's Keytruda
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The U.S. Food and Drug Administration has granted approval for an injectable version of Merck's blockbuster cancer drug Keytruda, marking a significant advancement in treatment options for patients with certain types of cancer. This subcutaneous formulation promises greater convenience over the traditional intravenous method, potentially improving patient adherence and reducing healthcare burdens. The decision, announced on September 19, 2025, underscores ongoing innovations in oncology amid rising demands for more accessible therapies.
Senate confirms Robert Califf as FDA commissioner
The U.S. Senate has confirmed Robert Califf to lead the Food and Drug Administration amid ongoing public health challenges. Califf, a cardiologist with prior FDA experience, was approved in a bipartisan vote. This move aims to stabilize the agency during debates over drug approvals and regulations.
Senator Hawley criticizes FDA approval of new abortion drug
Republican Senator Josh Hawley from Missouri has sharply criticized the Food and Drug Administration for approving a new abortion drug, raising concerns about women's safety and the agency's trustworthiness. In a letter to FDA Commissioner Robert Califf, Hawley accused the agency of prioritizing politics over science. The move highlights ongoing debates over abortion access and regulatory oversight.