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US FDA declines to approve Outlook’s eye disease drug for second time in 2025
01 Jan 2026 00:23 GMT
… prolonged push to bring the treatment to market and sending its … was testing the drug, Lytenava, for the treatment of wet age … declined to approve the drug, also called bevacizumab, in 2023, in … key trial conducted by Outlook to address some of the FDA’s …
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<![CDATA[US FDA issues CRL for ONS-5010's resubmitted BLA to Outlook Therapeutics]]>
31 Dec 2025 23:39 GMT
… and well-controlled noninferiority trial comparing ONS-5010 … from the other NORSE trials, provides sufficient evidence … EU and from the Medicines and Healthcare products … Drug Administration review of ONS-5010/LYTENAVA (bevacizumab-vikg) for the treatment …
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FDA Issues Complete Response Letter for ONS-5010 for Wet AMD
31 Dec 2025 22:46 GMT
… , the US Food and Drug Administration (FDA) has issued a Complete Response … ophthalmic formulation of bevacizumab for the treatment of wet AMD. Bevacizumab is a … based on the NORSE EIGHT trial results, as well as the …
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<![CDATA[FDA Issues Complete Response Letter for ONS-5010 for Wet AMD]]>
31 Dec 2025 22:46 GMT
… , the US Food and Drug Administration (FDA) has issued a Complete Response … ophthalmic formulation of bevacizumab for the treatment of wet AMD. Bevacizumab is a … based on the NORSE EIGHT trial results, as well as the …
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Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD
31 Dec 2025 21:15 GMT
… .S. Food and Drug Administration (FDA) has issued a … Authorization granted by the Medicines and Healthcare products … of care for bevacizumab for the treatment of retina diseases. … with developing and commercializing pharmaceutical product candidates, including …
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<![CDATA[December 2025: Year-End FDA Oncology Actions at a Glance ]]>
30 Dec 2025 21:25 GMT
… biparatopic HER2-targeting antibody-drug conjugate, for the treatment of adult patients with … previously received bevacizumab (Avastin).
Orphan Drug Designations
The FDA has granted orphan drug designation to …
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Biosimilars unlock use of bevacizumab in bowel cancer by NHS
29 Dec 2025 12:30 GMT
… biosimilar versions of the drug.
In recently published … them.
In clinical trials, adding bevacizumab to frontline fluoropyrimidine-based … approved bevacizumab for first- and second-line treatment in … by the National Cancer Medicines Advisory Group for …
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Alphamab Oncology Announces IND Application for a Phase II Clinical Study of HER2 Bispecific ADC Subcutaneous Co-formulation JSKN033 as First-line Treatment of Advanced Cervical Cancer was Officially Accepted by CDE
29 Dec 2025 09:18 GMT
… with or without bevacizumab as first-line treatment of advanced … Center for Drug Evaluation (CDE) of the National Medical Products … multicenter phase II clinical trial designed to evaluate the … ;II clinical trials of JSKN033 for the treatment of solid …
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Adding antibody treatment to chemo boosts outcomes for children with rare cancer: Study
25 Dec 2025 19:36 GMT
… treatment to usual chemotherapy, according to new results from a clinical trial … Cancer Research UK Clinical Trials Unit. Published in the … Cancer Research UK Clinical Trials Unit at the … an anti-tumour drug bevacizumab with chemotherapy drugs led to patient …
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<![CDATA[Top 5 Articles for Oncology Nurses and APPs in 2025]]>
31 Dec 2025 15:21 GMT
… RN, of Vanderbilt University Medical Center, gives a nurse … subcutaneous drug, key data from the drug’s approval … for whom no treatments are yet FDA approved.
Depending on … atezolizumab, cobimetinib plus atezolizumab, bevacizumab (Avastin) plus atezolizumab, or …