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Home » Topics » Regulatory » FDA

FDA
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Elderly person receiving shot

With FDA vaccine nod, Novavax takes ACIP of new COVID-19 rules

May 19, 2025
By Randy Osborne
No Comments
Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s COVID-19 vaccine Nuvaxovid, indicated for adults 65 and over and people 12-64 years old with at least one underlying condition that puts them at risk of severe outcomes from infection by the virus.
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Abstract molecules illustration
Biopharma regulatory actions and approvals April 2025

Atzumi and Vanrafia among 3 NMEs approved by US FDA in April

May 19, 2025
By Amanda Lanier
No Comments
The U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during the first four months of 2023 and 48 in 2022. Despite the decrease from last year, the 2025 total remains the second-highest in BioWorld’s records for this time frame.
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Zynyz

Incyte adds more FDA approvals for Zynyz in cancer

May 16, 2025
By Lee Landenberger
No Comments
Incyte Corp.’s Zynyz (retifanlimab-dlwr) has received another U.S. FDA approval and put some distance between it and a 2021 complete response letter. The FDA gave the humanized monoclonal antibody targeting PD-1 the nod for first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. That makes it the only approved first-line treatment for this cancer.
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Hand cupping ear to illustration hearing loss

Rznomics in $1.3B Lilly pact to make hearing loss RNA editor drug

May 15, 2025
By Marian (YoonJee) Chu
No Comments
Rznomics Inc. scored a potential ₩1.9 trillion (US$1.35 billion) global license option agreement with Eli Lilly and Co. to codevelop a novel RNA editing gene therapy to treat hereditary hearing loss.
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Inozyme’s INZ-701 shows promise for rare disease ENPP1 deficiency

May 15, 2025
By Karen Carey
No Comments
Just two months after Inozyme Pharma Inc. cut its workforce by 25% and prioritized activities to focus on a BLA filing for INZ-701 for ENPP1 deficiency, interim phase III data from its Energy 3 trial showed consistent safety and immunogenicity and increased phosphate levels in patients treated with the rare disease enzyme replacement therapy.
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Children’s Hospital of Philadelphia
ASGCT 2025

First bespoke gene editing therapy treats rare metabolic disease

May 15, 2025
By Anette Breindl
No Comments
Using a customized gene editing therapy, researchers at the Children’s Hospital of Philadelphia have reported success in treating an infant with a severe metabolic disorder. Kiran Musunuru, Barry J. Gertz Professor for Translational Research in the University of Pennsylvania’s Perelman School of Medicine, presented the case at the American Society of Gene and Cell Therapy’s 2025 annual meeting. The case study was simultaneously published in The New England Journal of Medicine.
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Cerebellum, brain stem, spinal cord
Neurology/psychiatric

Cure Rare Disease’s CRD-002 awarded orphan drug designation for spinocerebellar ataxia type 3

May 15, 2025
No Comments
The FDA has granted orphan drug designation to Cure Rare Disease’s CRD-002, an antisense oligonucleotide therapeutic for the treatment of spinocerebellar ataxia (SCA), including spinocerebellar ataxia type 3 (SCA3).
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Lung cancer illustration

US FDA clears Abbvie’s c-Met lung cancer ADC

May 14, 2025
By Karen Carey
No Comments
The U.S. FDA granted Abbvie Inc. accelerated approval for antibody-drug conjugate (ADC) Teliso-V (telisotuzumab vedotin), newly branded Emrelis, making it the first treatment for previously treated advanced non-small-cell lung cancer with high c-Met protein overexpression.
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Noah Medical

​FDA floods Noah Medical with multi-deviation warning letter

May 14, 2025
By Mark McCarty
Companies new to the world of U.S. FDA regulation are often unaware of how detailed the agency’s inspections are, which might be the case with the October-November 2024 inspection of Noah Medical Inc.
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RFK at Senate HELP meeting 5-14

Kennedy on HELP hot seat over budget, cuts and layoffs

May 14, 2025
By Mari Serebrov
No Comments
U.S. Health and Human Services Secretary Robert Kennedy made his first appearance May 14 before the Senate Health, Education, Labor and Pensions (HELP) Committee since his January confirmation hearing. Chaos, testy arguments, accusations and surprising agreements ensued.
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