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Follow Drugs & VaccinesThe FDA has approved Enspryng for thyroid eye disease, offering a new at-home subcutaneous option. Brytly, a nonprescription eye drop, was also approved for eye redness relief. Additionally, a zilucoplan autoinjector received approval, providing another self-administered treatment for generalized myasthenia gravis. These approvals expand treatment choices for patients.
The European Medicines Agency's CHMP has recommended marketing authorization for Foundayo (orforglipron), an oral GLP-1 receptor agonist. This once-daily tablet is intended for adults with type 2 diabetes and for weight management, offering a new oral treatment option. This recommendation could expand access to GLP-1 therapies in the EU.
The U.S. FDA has approved Brytly (apraclonidine ophthalmic solution, 0.125%) as a new nonprescription eye drop. It is intended for adults and children aged 12 and older to relieve eye redness from minor irritations, marking the first over-the-counter product containing apraclonidine. This approval provides consumers with a new accessible option for eye care.
The U.S. FDA has approved an autoinjector formulation of Zilbrysq (zilucoplan) for treating anti-acetylcholine receptor antibody-positive generalized myasthenia gravis in adults. This new delivery method aims to simplify self-administration for patients, improving convenience for those managing the chronic autoimmune condition. Commercial availability is expected in Q1 2027.
The European Medicines Agency's CHMP has recommended that Nyxoid (naloxone nasal spray) be made available without a prescription across all EU and EEA countries. This change in legal status aims to significantly broaden access to this emergency treatment for known or suspected opioid overdoses. Increased accessibility could help save lives by enabling faster intervention during overdose incidents.
The European Medicines Agency's CHMP has recommended approval for Eli Lilly's oral GLP-1 receptor agonist, Foundayo (orforglipron). This once-daily pill is intended for adult weight management and type 2 diabetes treatment. The recommendation positions Foundayo as a new oral alternative to existing injectable and other oral GLP-1 receptor agonists.
The U.S. FDA has approved Brytly (apraclonidine ophthalmic solution, 0.125%) as a new nonprescription eye drop. This marks the first over-the-counter eye drop containing apraclonidine, providing consumers with an expanded accessible option for relieving eye redness caused by minor irritations.
The U.S. FDA has approved Enspryng (satralizumab) for adults with thyroid eye disease (TED). This interleukin-6 receptor inhibitor is the first subcutaneous therapy for TED that patients or caregivers can administer at home after training. This decision, following a priority review, expands treatment options and marks Enspryng's second indication.
The FDA has approved Brytly (apraclonidine ophthalmic solution, 0.125%) as a new nonprescription eye drop. This marks the first over-the-counter eye drop containing apraclonidine, intended to relieve eye redness from minor irritations. The approval aims to broaden consumer access to effective nonprescription treatments.