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The FDA has approved Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with polycythemia vera. Besremi is an innovative monopegylated, long-acting interferon, which exhibits its cellular effects in polycythemia vera in the bone marrow. Besremi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infections disorders.
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The FDA has approved Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar with Humira (adalimumab). The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases, and this latest approval designates it as interchangeable across all of these indications.
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The FDA has approved Eprontia (topiramate) oral solution, 25mg/mL, the first and only liquid formulation of topiramate to be approved as a monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients aged 2 years and older; an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome in patients aged 2 years and older; and, as a preventive treatment of migraine in patients aged 12 years and older.
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The FDA has approved Rethymic (allogeneic processed thymus tissue-agdc), a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia.
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The FDA has approved Scemblix (asciminib) for the treatment of chronic myeloid leukemia in two distinct indications. The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors, based on major molecular response rate at 24 weeks; and full approval for adult patients with Ph+ CML-CP with the T315I mutation.
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The FDA has approved Seglentis (celecoxib/tramadol), which is comprised of a co-crystal form of celecoxib (an anti-inflammatory) and tramadol (an analgesic), for the treatment of acute pain in adults.
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The FDA has approved Susvimo (ranibizumab) injection, 100mg/mL, for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration who have previously responded to at least two anti-vascular endothelial growth factor injections.
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The FDA has approved Tavneos (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis and microscopic polyangiitis (the two main forms of ANCA vasculitis), in combination with standard therapy.
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The FDA has approved Tyrvaya (varenicline) nasal spray, 0.03mg, for the treatment of the signs and symptoms of dry eye disease. Tyrvaya is the first and only nasal spray approved for the treatment of dry eye disease.
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The FDA has approved Vuity (pilocarpine HCl) ophthalmic solution, 1.25%, for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. Vuity is the first and only FDA-approved eye drop to treat this common and progressive eye condition.
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The FDA has approved Xipere (triamcinolone acetonide) injectable suspension for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation.
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The FDA has approved Zimhi (naloxone HCl) injection, USP 5mg/0.5mL, for use in adults and children for the treatment of an opioid emergency, such as an overdose or a possible overdose with signs of breathing problems and severe sleepiness or not being able to respond.
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The FDA has approved Dextenza (dexamethasone) ophthalmic insert, 0.4mg, for intracanalicular use, for the treatment of ocular itching associated with allergic conjunctivitis.
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The FDA has approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
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The FDA has approved Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer whose tumors express PD-L1≥1%, as determined by an FDA-approved test.
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The FDA has approved Dyanavel XR (amphetamine), extended-release once-daily tablets, CII, for the treatment of attention-deficit hyperactivity disorder in patients aged 6 years or older. In a clinical study in adults, Dyanavel XR tablets demonstrated bioequivalence to Dyanavel XR (amphetamine) extended-release oral suspension.
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The FDA has approved Verzenio (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test.
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Artnaturals is voluntarily recalling ten manufacturing lots of Artnaturals 8-oz scent-free hand sanitizer. FDA testing identified 8-oz bottles of scent-free hand sanitizer from a single manufacturing lot: G20128A contained several impurities.
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Bryant Ranch Prepack is voluntarily recalling 1 lot of methocarbamol 500mg tablets to the consumer level. The bottles labeled as methocarbamol 500mg tablets have been found to contain methocarbamol 750mg tablets. The affected methocarbamol 500mg lots include the following lot number: 163935, and expiration date: 10/22.
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Lupin Pharmaceuticals is voluntarily recalling all batches of irbesartan tablets USP 75mg, 150mg, and 300mg and irbesartan and hydrochlorothiazide tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US, to the consumer level. Analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan.
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Merck is voluntarily recalling one lot of Cubicin (daptomycin) 500mg, Lot 934778, Exp June 2022. Approximately 22,000 vials are affected by this recall. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of Cubicin after reconstitution.
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SterRx announced the voluntary nationwide recall of approximately 240 lots within their expiry period due to equipment and process issues that could lead to a lack of sterility assurance for products intended to be sterile. Customers are being notified by fax, email, FedEx, and/or certified mail, which includes arrangements for return of all recalled product.
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Teligent is voluntarily recalling five lots of lidocaine HCl topical solution 4%, 50mL in a screw cap glass bottle, to the user level. The product is being recalled because testing has found it to be super-potent based on an out-of-specification result obtained at the 18-month stability timepoint.
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The FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure to hand sanitizer has been reported in all age groups; however, it has occurred most often in children.
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