Some deaf children are hearing again because of a new gene therapy
2026년에 FDA가 OTOF 유전자 치료제인 Otarmeni를 가속 승인하면서 선천성 난청 아동들이 청력을 회복하는 사례가 보고되고 있다. 이 치료법은 중국 푸단대학과 미국 Mass Eye and Ear가 공동으로 진행한 국제 임상시험을 기반으로 하며, 단일 주사로 청각 기능을 회복시키는 혁신적인 유전자 치료 기술이다. 치료 후 아이들이 소리에 반응하는 모습이 확인되면서 가족들에게 큰 감동을 주고 있다.

https://www.vox.com/future-perfect/487590/gene-therapy-crispr-deafness-food-and-drug-administration

#genetherapy #deafness #otof #fdaapproval #clinicaltrial

Some deaf children are hearing again because of a new gene therapy

A new gene therapy cure is the latest in a quiet 27-year resurrection of a once-dead field.

Vox
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Urge Virbac to Begin #FDAApproval for Interferon Omega - Help cats with FIV, FeLV & More
My cat, TomTom, is FIV+ and suffers from chronic stomatitis, a painful condition that has caused some of his teeth to fall out. The only medication that offers hope for both his FIV and stomatitis is Interferon Omega. Interferon Omega is widely used in Europe and Asia to treat cats with FIV, FeLV, stomatitis, and other chronic immune-related conditions. Studies and real-life outcomes have shown its ability to reduce symptoms, improve quality of life, and in many cases, prolong survival. Despite this, U.S. pet owners are left in limbo. Importing the drug is risky as cold-chain requirements make it vulnerable to spoilage in transit, customs can delay or reject the shipment, and the cost for a single course of treatment can exceed $600. Worst of all, most suppliers require buyers to accept these risks upfront, meaning that if the medication arrives warm or unusable, there is no refund or replacement.
https://www.change.org/p/urge-virbac-to-begin-fda-approval-for-interferon-omega-help-cats-with-fiv-felv-more?recruiter=933723872&recruited_by_id=d704a360-262d-11e9-888b-d7fe368e0a9d&utm_source=share_petition&utm_campaign=psf_combo_share_initial&utm_term=97cb52844d18479498af3f4659cf9e1b&utm_medium=copylink&utm_content=cl_sharecopy_490654878_en-US%3A3&share_id=JtC2QHWZHY
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Urge Virbac to Begin FDA Approval for Interferon Omega - Help cats with FIV, FeLV & More

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Kolon Group reduces financial risk from Invossa gene therapy as legal challenges ease, boosting corporate value with the drug’s U.S. market potential nearing $7.5 billion.
#YonhapInfomax #KolonGroup #Invossa #LegalRisks #TGC #FDAApproval #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=104258
Kolon Eases Financial Burden from Invossa Development as Legal Hurdles Gradually Clear

Kolon Group reduces financial risk from Invossa gene therapy as legal challenges ease, boosting corporate value with the drug’s U.S. market potential nearing $7.5 billion.

Yonhap Infomax

California doctor first to face lawsuit under Texas' bounty hunter abortion pill ban

https://fed.brid.gy/r/https://www.advocate.com/politics/california-doctor-texas-abortion-pill

The FDA’s Lax Generic Drug Rules Can Put Patients’ Lives at Risk

Generic drugs are supposed to be equivalent to brand-name medications — but the FDA doesn’t always ensure that.

https://murica.website/2026/01/the-fdas-lax-generic-drug-rules-can-put-patients-lives-at-risk/

The FDA’s Lax Generic Drug Rules Can Put Patients’ Lives at Risk – The USA Potato

Florida and Texas launch 'legal attack' in push to restrict abortion medication nationally

https://fed.brid.gy/r/https://www.advocate.com/florida-texas-mifepristone-abortion-lawsuit

Alteogen Co. posted a 900% jump in Q3 revenue, driven by the commercialization of its ALT-B4 platform and milestone payments from FDA-approved Keytruda SC, marking a major turnaround in profitability and global expansion momentum.
#YonhapInfomax #Alteogen #ALTB4 #Q3Revenue #Keytruda #FDAApproval #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=90913
Alteogen Posts 900% Surge in Q3 Revenue as ALT-B4 Commercialization Accelerates

Alteogen Co. posted a 900% jump in Q3 revenue, driven by the commercialization of its ALT-B4 platform and milestone payments from FDA-approved Keytruda SC, marking a major turnaround in profitability and global expansion momentum.

Yonhap Infomax
Celltrion has received additional FDA approval for its Yuflyma 10mg pre-filled syringe, expanding its US high-concentration biosimilar lineup for pediatric autoimmune treatment.
#YonhapInfomax #Celltrion #Yuflyma #FDAApproval #Biosimilar #JuvenileIdiopathicArthritis #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=88896
Celltrion Secures Additional FDA Approval for Yuflyma 10mg Formulation in US

Celltrion has received additional FDA approval for its Yuflyma 10mg pre-filled syringe, expanding its US high-concentration biosimilar lineup for pediatric autoimmune treatment.

Yonhap Infomax
Celltrion has received FDA approval for additional pediatric indications of Yuflyma in the US, targeting pediatric uveitis and hidradenitis suppurativa, and aims to expand its market presence as exclusivity for the original drug expires.
#YonhapInfomax #Celltrion #Yuflyma #FDAApproval #PediatricIndications #Adalimumab #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=86225
Celltrion Secures Additional Pediatric Indications for Yuflyma in US

Celltrion has received FDA approval for additional pediatric indications of Yuflyma in the US, targeting pediatric uveitis and hidradenitis suppurativa, and aims to expand its market presence as exclusivity for the original drug expires.

Yonhap Infomax
Celltrion has secured US FDA approval for its Eylea biosimilar, Eydenzelt, expanding its US portfolio, though commercial launch is delayed amid ongoing patent litigation with Regeneron.
#YonhapInfomax #Celltrion #FDAApproval #Eydenzelt #Biosimilar #PatentDispute #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=84948
Celltrion Receives US FDA Approval for Ophthalmic Drug ‘Eylea’

Celltrion has secured US FDA approval for its Eylea biosimilar, Eydenzelt, expanding its US portfolio, though commercial launch is delayed amid ongoing patent litigation with Regeneron.

Yonhap Infomax