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

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

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

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

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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March 13, 2025
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Senate committee advances NIH, FDA leaders' nominations

Senate committee advances NIH, FDA leaders' nominations

The United States Senate Committee on Health, Education, Labor and Pensions voted to advance the nominations of probable new NIH and FDA leaders to the full senate.

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March 12, 2025
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FDA grants fast track designation to X-linked retinoschisis treatment

FDA grants fast track designation to X-linked retinoschisis treatment

  The FDA granted fast track designation to ATSN-201 for the treatment of X-linked retinoschisis, according to a press release from Atsena Therapeutics.

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March 12, 2025
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FDA approves Soliris for patients aged 6 years and up with generalized myasthenia gravis

FDA approves Soliris for patients aged 6 years and up with generalized myasthenia gravis

The FDA has approved an expanded indication of Soliris, an IV-administered monoclonal antibody for patients aged 6 years and older with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive.

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March 11, 2025
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FDA accepts new drug application for SYD-101 to treat pediatric myopia progression

FDA accepts new drug application for SYD-101 to treat pediatric myopia progression

The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription Drug User Fee Act date of Oct. 23, according to a press release from Sydnexis.

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March 07, 2025
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FDA approves omalizumab biosimilar Omlyclo

FDA approves omalizumab biosimilar Omlyclo

The FDA approved Celltrion’s omalizumab biosimilar, Omlyclo, for the treatment of multiple conditions including asthma and food allergy, according to an agency press release.

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March 06, 2025
3 min read
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Makary vows FDA will uphold 'gold standard of trusted science' during Senate hearing

Makary vows FDA will uphold 'gold standard of trusted science' during Senate hearing

Lawmakers grilled Martin Makary, MD, MPH, on transparency, his plans for mifepristone and his stance on the recently cancelled Vaccine Advisory Committee meeting during Thursday’s senate hearing to be the next FDA commissioner.

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