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Dupixent® (dupilumab) Pivotal Trial Met All Primary and Secondary Endpoints, Reducing Signs and Symptoms of Allergic Fungal Rhinosinusitis (AFRS); sBLA Accepted for FDA Priority Review
07 Nov 2025 13:00 GMT
… a “live vaccine” right before and during treatment with DUPIXENT. … DUPIXENT. Call your doctor for medical advice about side effects … of prescription drugs to the FDA. Visit www.fda.gov… future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or …
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Press Release: ACAAI: Sanofi and Regeneron’s Dupixent pivotal study met all primary and secondary endpoints, reducing signs and symptoms of allergic fungal rhinosinusitis; sBLA accepted for FDA priority review
07 Nov 2025 13:00 GMT
… the US Food and Drug Administration (FDA) accepted for priority … into medicine has led to numerous approved treatments and … system to invent medicines and vaccines that treat and … the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or …
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VIDEO: Extension studies shed light on wet AMD treatments
06 Nov 2025 20:03 GMT
… the AVONELLE-X trial, the PULSAR trial and the Portal … 80% of patients extending treatment beyond 12 weeks and … is that we have great medications that are effective, safe … /recruiting trials, guidelines
Clinical Guidance, Healio CME, FDA news
Healio…
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Alvotech faces FDA setback for its Simponi biosimilar AVT05
04 Nov 2025 09:09 GMT
… .S. Food and Drug Administration (FDA) because of issues … Iceland.
The biosimilar-focused biotech was anticipating that AVT05 … filed with the European Medicines Agency (EMA) in … Eylea (aflibercept) sold by Regeneron Pharmaceuticals and Bayer for the treatment …
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Communiqué de presse : ACAAI : L’étude pivot Dupixent menée par Sanofi et Regeneron a atteint l’ensemble de ses critères d’évaluation principaux et secondaires, réduisant les signes et symptômes de la rhinosinusite fongique allergique...
07 Nov 2025 13:00 GMT
… US Food and Drug Administration (FDA) a récemment … concevons des médicaments et des vaccins qui traitent … pharmaceutiques, ainsi que les programmes gouvernementaux tels que Medicare et Medicaid … procédures connexes concernant EYLEA® [aflibercept] Injection …
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Biosimilar Monthly Roundup: October 2025
06 Nov 2025 23:44 GMT
… highly purified proteins than clinical trials, whose outcomes can be … Robert F. Kennedy Jr stating the guidance replaces “bureaucracy … referencing Eylea.4 This marks Celltrion’s first FDA-approved … settings by proving the drug';s integrity withstands the …
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Relay Therapeutics Reports Third Quarter 2025 Financial Results and Corporate Updates
06 Nov 2025 21:05 GMT
… Habib Dable, former biotech CEOs with launch and … S. Pharmaceuticals; Executive Vice President, Global Head Specialty Medicine; …
Breast Cancer Clinical Trial Execution
Continued Phase … clinical trials or the development of Relay Therapeutics’ drug candidates …
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Regulatory tracker: FDA pushes back decision on Rhythm's potential Imcivree expansion
02 Jul 2025 21:48 GMT
… FDA approval in the same indications Eylea currently holds. In trials … through regular doctor visits and scans … medication for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), the drug … As Vertex Pharmaceuticals moves ahead with the …
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Human medicines European public assessment report (EPAR): Vgenfli, aflibercept, Date of authorisation: 14/08/2025, Status: Authorised
20 Jun 2025 10:00 GMT
… the medicine are considered to be comparable to those of Eylea.
For …
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Alvotech, Advanz Pharma Receive MHRA Marketing Authorizations for Gobivaz
06 Nov 2025 16:03 GMT
… biotech company specializing in the development and manufacture of biosimilar medicines … for patients worldwide, and Advanz Pharma Holdco Limited, a pharmaceutical … formats, for the treatment of rheumatoid arthritis, … to Eylea (aflibercept).
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