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    • Eylea

Eylea Newsletter
  • FDA Issues Complete Response Letter to Regeneron for EYLEA HD sBLA on Extended Dosing Intervals 22 Apr 2025 16:59 GMT

    … Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA … and PHOTON phase 3 trials, which were published in … 8 mg in the treatment of macular edema following … European Medicines Agency. Approved Indications and Safety Overview EYLEA HD …

  • Regeneron Announces New Investment in Manufacturing of its Industry-Leading Biologic Medicines 22 Apr 2025 10:00 GMT

    … (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) … Biotechnologies (“Fujifilm”) to manufacture and supply bulk drug … into medicine has led to numerous approved treatments and … product candidates to clinical trials, therapeutic applications, …

  • FDA Issues CRL for Extended Dosing of Eylea HD 21 Apr 2025 21:58 GMT

    The FDA has issued a complete response … said they are evaluating the FDA’s decision. The company is … (monthly) dosing across approved indications. Eylea 2 mg is already approved … ), macular edema, and diabetic retinopathy. Eylea HD is approved for patients …

  • FDA does not approve additional extended dosing intervals for Eylea HD 22 Apr 2025 03:00 GMT

    … FDA did not approve the supplemental biologics license application for Eylea … extending the dosing intervals for Eylea HD, according to a … 16 weeks, if approved. Eylea HD (aflibercept injection 8 mg … “Regeneron is evaluating the FDA’s decision and will determine …

  • FDA Delivers CRL for Longer Dosage Intervals in Aflibercept for DME, Wet AMD 21 Apr 2025 23:47 GMT

    … completed 2 years of treatment and participated in the … pressure all recorded. The PHOTON trial (NCT04429503) was also the … similarly to the PULSAR trial, with 658 patients randomized … update-eylea-hdr-aflibercept-injection-8-mg Jeremias S. FDA approves …

  • Regeneron announces FDA issues CRL for aflibercept 8 mg (Eylea HD) sBLA 21 Apr 2025 14:08 GMT

    … Drug Administration (FDA) has issued a complete response letter (CRL) to Regeneron Pharmaceuticals … PULSAR and PHOTON trials for aflibercept 8 … Medicines Agency in early April. Indications and safety information Both EYLEA … treatment of wAMD, DME and DR. EYLEA …

  • FDA rejection of extended dosing interval is another piece of bad news for Regeneron’s Eylea HD 21 Apr 2025 17:52 GMT

    … new formulation of eye disease treatment Eylea needed “a few more … . “Regeneron is evaluating the FDA’s decision and will determine … forward in due course,” the drugmaker added. The company is … after the FDA accepted Regeneron’s application for Eylea HD to …

  • FDA approves Dupixent for hives, rejects new Eylea dosing schedule 21 Apr 2025 03:23 GMT

    The FDA made two de­ci­sions on Re­gen­eron’s best-sell­ing drugs Fri­day, hand­ing down one ap­proval and one re­jec­tion. The ap­proval came for Dupix­ent, the megablock­buster Re­gen­eron … Sign up to read this article for free. Get free access to a …

  • FDA issues CRL for aflibercept 8 mg extended dosing for all indications 18 Apr 2025 21:19 GMT

    … to Regeneron Pharmaceuticals for a supplemental new drug application to … would reduce treatment burden in eligible patients. EYLEA HD was … and 16 pivotal trials, aflibercept and EYLEA HD are approved … of geographic atrophy (SIENNA trial), as well as efforts …

  • FDA Accepts Regeneron’s sBLA for EYLEA HD for Priority Review 18 Apr 2025 16:49 GMT

    … .S. Food and Drug Administration (FDA) has accepted Regeneron’s … adherence to treatment schedules. QUASAR Trial Supports EYLEA HD in … prior pivotal trials. The most notable ocular treatment-emergent … application with the European Medicines Agency (EMA) to …

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