The FDA has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.
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The FDA has expanded the approval of CellCept (mycophenolate mofetil) to include prophylaxis of organ rejection in pediatric recipients of allogeneic heart and liver transplants. CellCept is now indicated for the prophylaxis of organ rejection in adult and pediatric recipients aged 3 months and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
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The FDA has approved Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
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The FDA has approved expanded indications for Hulio (adalimumab-fkjp), a biosimilar to Humira (adalimumab), providing for expansion of the indication of polyarticular juvenile idiopathic arthritis to now include patients aged 2 years and older and expansion of the indication of Crohn's disease to now include patients aged 6 years and older.
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The FDA has approved Imcivree (setmelanotide), a melanocortin-4 receptor agonist, for patients with Bardet-Biedl syndrome (BBS). With this approval, Imcivree is indicated for chronic weight management in adult and pediatric patients aged 6 years and older with monogenic or syndromic obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency, or BBS.
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The FDA has approved Olumiant (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata, available as 4mg, 2mg, and 1mg tablets.
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The FDA supplemental New Drug Application for Qsymia (phentermine/topiramate) extended-release capsules as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older with body mass index in the 95th percentile or greater standardized for age and sex.
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The FDA has approved Riabni (rituximab-arrx), a biosimilar to Rituxan, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies. Riabni is already approved for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
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The FDA has approved Skyrizi (risankizumab-rzaa) as the first and only specific interleukin-23 inhibitor for the treatment of adults with moderately to severely active Crohn's disease.
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Tafinlar + Mekinist
The FDA has approved Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Tafinlar + Mekinist is the first and only BRAF/MEK inhibitor to be approved with a tumor-agnostic indication for solid tumors carrying the BRAF V600E mutation, and it is the only BRAF/MEK inhibitor approved for use in pediatric patients.
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The FDA has approved an expanded indication for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) to include children aged 6 weeks through 17 years. Vaxneuvance is now indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals aged 6 weeks and older.
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The FDA has approved Xalkori (crizotinib) for inflammatory myofibroblastic tumors (IMTs) in adults and children aged one or older with IMTs that carry a mutation in the ALK gene that cannot be removed surgically and have progressed despite prior therapies.
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The FDA has approved expansion of the indication for Zulresso (brexanolone) injection to include patients aged 15 years and older diagnosed with postpartum depression and addition of corresponding study information to applicable sections of the package insert, medication guide, and REMS.
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Bryant Ranch Prepack Morphine Sulfate
Bryant Ranch Prepack Inc. is voluntarily recalling one lot of morphine sulfate 30mg extended-release tablets (comprised of 10 bottles) and one lot of morphine sulfate 60mg extended-release tablets (comprised of 10 bottles), to the consumer level. The products have been found to have incorrect labeling where bottles labeled as morphine sulfate 60mg extended-release tablets contain morphine sulfate 30mg extended-release tablets, and bottles labeled as morphine sulfate 30mg extended-release tablets may contain morphine sulfate 60mg extended-release tablets.
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Buzzagogo Allergy Bee Gone for Kids Nasal Swab Remedy
Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast and mold and may contain the bacteria Bacillus cereus.
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Green Pharmaceuticals SnoreStop NasoSpray
Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray, packaged in 0.3 fl. oz. (9mL) bottles, to the consumer level. FDA testing found product to contain microbial contamination identified as Providencia rettgeri.
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Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of propofol injectable emulsion, USP (containing benzyl alcohol), 100mL single patient use glass flip-top vial; lot DX9067, to the user level, due to a visible particulate observed in a single vial during annual examination of retention samples.
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Latin Foods Market Artri King Reforzado con Ortiga y Omega 3
Latin Foods Market is voluntarily recalling one lot, LOTE 334 21, of Artri King Reforzado con Ortiga y Omega 3 tablets to the consumer level. FDA analysis has found the product to be tainted with diclofenac and dexamethasone. Diclofenac and dexamethasone are both FDA-approved drugs. The presence of diclofenac and dexamethasone in Artri King Reforzado con Ortiga y Omega 3 renders it an unapproved drug for which the safety and efficacy have not been established and, therefore, subject to recall.
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Loud Muscle Science Launch Sequence
Loud Muscle Science, LLC is voluntarily recalling certain Launch Sequence products to the consumer level. Laboratory analysis undertaken at the request of Loud Muscle Science, LLC found the products to be tainted with tadalafil. The presence of tadalafil in the Launch Sequence products makes these products unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
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Mylan Pharmaceuticals Insulin Glargine
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of insulin glargine (insulin glargine-yfgn) injection, 100 units/mL, 3mL prefilled pens, which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee pen but the unbranded insulin glargine-yfgn pens. This batch is being recalled due to the potential for the label to be missing on some pens.
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Plastikon Healthcare Milk of Magnesia and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone
Plastikon Healthcare, LLC is voluntarily recalling one lot of milk of magnesia 2400mg/10mL oral suspension, one lot of milk of magnesia 2400mg/30mL oral suspension, eleven lots of magnesium hydroxide 1200mg/aluminum hydroxide 1200mg/simethicone 120mg per 30mL oral suspension, and two lots of magnesium hydroxide 2400mg/aluminum hydroxide 2400mg/simethicone 240mg per 30mL oral suspension, to the consumer level. The products are being recalled due to microbial contamination.
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Vi-Jon Magnesium Citrate Saline Laxative
Vi-Jon, LLC is expanding its voluntary recall to include all lots of magnesium citrate saline laxative oral solution lemon flavor, 10 fl. oz. (296mL) within expiry to the consumer level. The recall was initiated after microbial testing identified the presence of Gluconacetobacter liquefaciens.
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