The FDA has approved Aduhelm (aducanumab-avwa) as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain. The accelerated approval has been granted based on data from clinical trials demonstrating the effect of Aduhelm on reducing amyloid beta plaques, a biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
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The FDA has approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (azelastine hydrochloride) nasal spray, 0.15%, for seasonal and perennial allergic rhinitis, commonly known as allergies, for adults and children aged six years and older.
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The FDA has approved Brexafemme (ibrexafungerp) tablets for oral use in patients with vulvovaginal candidiasis, also known as vaginal yeast infection. Brexafemme represents the first approved drug in a novel antifungal class in more than 20 years.
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The FDA has approved Lybalvi (olanzapine/samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. Lybalvi is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity.
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FDA has approved Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for the
prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae
(pneumococcus) serotypes in the vaccine in adults aged 18 years and older.
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The FDA has approved Rezipres (ephedrine hydrochloride) injection for the treatment of clinically important hypotension occurring in the setting of anesthesia.
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The FDA has approved Rylaze (asparaginase erwinia chrysanthemi
(recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic
regimen for the treatment of acute lymphoblastic leukemia or lymphoblastic
lymphoma in pediatric and adult patients aged one month and older who have
developed hypersensitivity to E. coli-derived asparaginase.
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The FDA has approved Ryplazim (plasminogen, human-tvmh) for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemiaf). With this approval, Ryplazim becomes the first FDA-approved therapy for this rare genetic disorder.
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The FDA has approved StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).
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The FDA has approved Tembexa (brincidofovir) tablets and oral suspension approval for the treatment of smallpox. Tembexa is approved for adult and pediatric patients, including neonates.
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The FDA has approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement. Truseltiq is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR.
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The FDA has approved Verkazia (cyclosporine) ophthalmic emulsion, 0.1%, for the treatment of vernal keratoconjunctivitis in children and adults.
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The FDA has approved Wegovy (semaglutide) injection 2.4mg for adults with obesity (BMI ≥30) or overweight (excess weight) (BMI ≥27) who also have weight-related medical problems to help them lose weight and keep the weight off.
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The FDA has approved Ayvakit (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (SM), including aggressive SM, SM with an associated hematological neoplasm and mast cell leukemia. For the first time, advanced SM patients can now receive a targeted therapy designed to potently and selectively inhibit D816V mutant KIT, the central driver of the disease.
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The FDA has approved expansion of the pediatric indication of Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as aged 3 years, regardless of HCV genotype or liver disease severity. The FDA approved a New Drug Application for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200mg/velpatasvir 50mg and sofosbuvir 150mg/velpatasvir 37.5mg) developed for use by younger children who cannot swallow tablets.
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The FDA has extended its approval of Mavyret (glecaprevir/pibrentasvir) in oral pellet formulation for the treatment of hepatitis C in children aged 3 and older.
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FDA has approved Pradaxa (dabigatran etexilate) oral pellets to treat children aged
3 months to less than 12 years with venous thromboembolism directly after they
have been treated with a blood thinner given by injection for at least five
days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots
among patients aged 3 months to less than 12 years who completed treatment for
their first venous thromboembolism.
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The FDA has approved expanded use of Trikafta
(elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with
cystic fibrosis (CF) aged 6 through 11 years who have at least one F508del mutation in
the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a
mutation in the CFTR
gene that is responsive to Trikafta based on in vitro data. The FDA previously approved
Trikafta for use in people with CF who are aged 12 years and older with at
least one copy of the F508del
mutation or one copy of a mutation that is responsive in vitro. An
additional dosage strength of Trikafta tablets is now available (elexacaftor
50mg/tezacaftor 25mg/ivacaftor 37.5mg and ivacaftor 75mg) in connection with
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The FDA has approved the expanded use of Ultomiris (ravulizumab-cwvz) to include children (aged one month and older) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris, a long-acting C5 inhibitor that offers immediate, complete and sustained complement inhibition, is now the first and only FDA-approved medicine for children and adolescents with PNH.
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Ardil Comercial Limar Hand Sanitizer
Ardil Comercial is voluntarily recalling one lot of Limar Hand Sanitizer, packaged in 4-oz bottles, to the consumer level. The hand sanitizer is being recalled because it is packaged in containers that resemble water bottles. The product poses a risk of ingestion.
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The FDA is alerting patients and healthcare professionals to Pfizer’s voluntary recall of nine lots of the smoking cessation drug Chantix (varenicline) to the warehouse level. The company is recalling varenicline because it may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above the FDA’s acceptable intake limit.
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Prairie Wolf Spirits Hand Sanitizer
Prairie Wolf Spirits, Inc. is voluntarily recalling all lots of Prairie Wolf Distillery hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles to the consumer level. The recall does not affect any other hand sanitizer products from Prairie Wolf Distillery. The product poses a risk of ingestion.
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Teva Pharmaceuticals Topotecan Injection
Teva Pharmaceuticals has initiated a voluntary recall of lot 31328962B of Topotecan Injection 4mg/4mL (1mg/mL) to the retail/institutional level in the US. This voluntary recall was initiated based on a complaint received from a pharmacy after a single glass particle was observed inside one vial. After further examination of the complaint sample, two other particulates were found and identified as one grey silicone particle and one translucent, colorless cotton fiber.
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Viona Pharmaceuticals Metformin Hydrochloride
Viona Pharmaceuticals Inc. is voluntarily recalling two lots of metformin hydrochloride extended-release tablets, USP 750mg, to the retail level. The two lots of metformin hydrochloride extended-release tablets, USP 750mg have been found to contain levels of Nitrosodimethylamine impurities above acceptable daily limits.
Learn more about the Viona Pharmaceuticals metformin hydrochloride recall