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March 28, 2025
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FDA expands Pluvicto indication for earlier use in patients with prostate cancer

The FDA approved a radioligand therapy for earlier use prior to chemotherapy in patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer, according to a Novartis-issued press release.

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March 28, 2025
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FDA authorizes marketing of first chlamydia, gonorrhea, trichomoniasis home test

The FDA has granted Visby Medical authorization to market their at-home, over-the-counter diagnostic test that detects chlamydia, gonorrhea and trichomoniasis, according to a press release.

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March 28, 2025
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FDA grants approval to two more denosumab biosimilars

The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, according to an industry press release.

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March 27, 2025
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FDA approves first therapy to treat hyperphagia in Prader-Willi syndrome

The FDA has approved the first therapy to address hyperphagia for children and adults aged 4 years and older with Prader-Willi syndrome, Soleno Therapeutics announced.

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March 26, 2025
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Senate confirms Trump's picks to lead NIH and FDA

The Senate voted Tuesday to confirm the heads of two major federal health agencies.

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March 26, 2025
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FDA approves first new antibiotic for uncomplicated UTIs in nearly 30 years

The FDA approved gepotidacin for the treatment of uncomplicated UTIs in women and adolescent girls aged 12 years or older, GSK announced.

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March 20, 2025
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FDA launches online database for chemical contaminant levels in food

The FDA unveiled the Chemical Contaminants Transparency Tool, a searchable online database that provides a list of chemical contaminant types and levels used to evaluate possible harm in foods meant for human consumption.

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March 18, 2025
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Nipocalimab nets FDA fast-track designation for Sjögren’s disease

The FDA has granted fast-track designation to nipocalimab for the treatment of Sjögren’s disease, according to a press release from Johnson & Johnson.

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March 14, 2025
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FDA approves expanded label for Iluvien

  The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye, according to a press release from ANI Pharmaceuticals.

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March 13, 2025
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FDA issues limited acne product recalls, AAD releases statement on benzoyl peroxide

The FDA released results from its investigation of benzene in acne products containing benzoyl peroxide. In light of these findings, the American Academy of Dermatology updated its statement on benzoyl peroxide in personal care products.

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