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MacuMira launches first Health Canada-approved device for AMD treatment
24 Sep 2025 09:00 GMT
… MacuMira Medical Devices recently introduced the first Health Canada-approved treatment to … date, and a randomised controlled trial published in the International Journal … Canada also approved Eylea’s Aflivu (aflibercept) for the treatment of various …
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Scholar Rock In Spotlight After FDA Refuses To Approve Muscular Atrophy Treatment Over Third-Party Manufacturing Facility Issues
23 Sep 2025 18:13 GMT
… to approve its Apitegromab drug for the treatment of patients with … company stated that the FDA raised concerns identified during a … for approval by the European Medicines Agency, and a decision … rule on two of its EYLEA HD Injection regulatory submissions …
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Scholar Rock's Spinal Muscular Atrophy Drug Faces FDA Delay Over Catalent Indiana Inspection
23 Sep 2025 15:56 GMT
… Catalent Indiana’s remediation of the FDA observations, Scholar Rock … review by the European Medicines Agency, and a decision … access.
In August, Regeneron Pharmaceuticals Inc. REGN said it … S. Food and Drug Administration (FDA) applications for EYLEA HD (pre- …
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FDA rejects Scholar Rock's SMA drug, citing issues at Novo's Catalent Indiana site
23 Sep 2025 14:40 GMT
… FDA sent a complete response letter (CRL) to the Massachusetts biotech … two more FDA decisions relating to Eylea were being … a potential treatment to pair with obesity drugs. In June … address muscle deterioration. These medicines, all blockbusters, include …
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Much Maligned Manufacturing Site Trips Up Scholar Rock’s Spinal Muscular Atrophy Drug
23 Sep 2025 12:59 GMT
… with Catalent Indiana regarding the FDA’s observations, building up … said on Tuesday. The biotech has not yet provided specific … biotech dropped 12.5% in pre-market trading Tuesday.
That the FDA … its high-dose formulation of Eylea have been pushed into the …
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Comparisons of Early Changes of Vascular Structure After Treatment with Faricimab and Aflibercept in Eyes with Macular Neovascularization by OCT Angiography
23 Sep 2025 08:49 GMT
… Basel, Switzerland) or Aflibercept (Eylea; Bayer, Basel, Switzerland) … treatment was not consistently documented in the medical records … VEGF drugs in age-related macular degeneration. Pharmaceutics. 2019 … -related macular degeneration trials of faricimab with …
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Bayer moves Parkinson’s cell therapy into Phase III trial
22 Sep 2025 10:32 GMT
… near term, Bayer’s pharmaceutical unit is banking on … new prostate cancer drug Nubeqa, kidney treatment Kerendia and a … prevention drug Xarelto and an older version of eye medication Eylea.
The … Cambridge University, U.S. biotech firm Aspen Neuroscience, and …
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Regeneron Donates Ebola Treatment for Use in Countries Most at Risk of Outbreaks
19 Sep 2025 11:00 GMT
… treatment approved by the U.S. Food and Drug Administration (FDA … ) -- Regeneron Pharmaceuticals, Inc. ( … vaccine prior to their enrollment in the PALM clinical trial … biotechnology company that invents, develops and commercializes life-transforming medicines …
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Parkinson's disease at forefront of Bayer bet on cell and gene therapies
25 Sep 2025 07:24 GMT
… experimental Parkinson’s disease treatment designed to replace dopamine- … needs success in the pharmaceutical sector to overcome past … a trial, though cancer drug Nubeqa and kidney disease medicine Kerendia … well as U.S. biotech company Aspen Neuroscience.
Among …
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European Commission Grants Marketing Authorization for EYLUXVI, Alteogen’s Aflibercept Biosimilar
24 Sep 2025 16:11 GMT
… a biosimilar of aflibercept (Eylea) developed by Alteogen in … the European Union for the treatment of neovascular (wet) age … opinion from the Committee for Medicinal Products for Human Use …
In the randomized, controlled trial, 431 patients with wet …