FDA
FDA biologics chief Vinay Prasad to leave agency at end of April
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Dr. Vinay Prasad, who leads the FDA division that oversees vaccines and other biological products, will leave the agency at the end of April, FDA Commissioner Marty Makary told staff in an email. It will be Prasad’s second departure in less than a year after a brief exit last summer amid clashes over high-profile drug and vaccine reviews.
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.
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.
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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.
FDA Chief Marty Makary stated that an anticipated autism report has not yet been written, describing a Wall Street Journal story on the matter as premature. He indicated the report would be released within a month. Meanwhile, Kenvue's stock dropped following related news.
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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.