FDA
Poll, high‑profile cases fuel bipartisan push to revisit mail‑order abortion pill rules
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A new national survey and a string of coercion cases are intensifying calls from Republican lawmakers, state attorneys general, and advocacy groups for the FDA to restore tighter safeguards on abortion medications—pressure that comes even as federal health officials say they are reviewing mifepristone’s safety and the FDA has cleared a second generic version.
The US Food and Drug Administration (FDA) has approved mitapivat (brand name Aqvesme) for treating anaemia in adults with thalassaemia, working by improving red blood cell energy. The twice-daily pill can be taken by patients who need regular blood transfusions or those who do not. Experts say it could transform disease management in high-burden countries like India.
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Brain implant developer Paradromics has secured approval from the US Food and Drug Administration to conduct an early-stage human trial for its device. The Austin-based startup aims to test the high-bandwidth implant to restore speech in individuals with extremely limited movement. The company announced the milestone on Thursday.
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.
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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.
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.