Vivjoa From Mycovia Pharmaceuticals, Inc
The FDA approved a new azole antifungal for recurrent vulvovaginal candidiasis.
Voquezna Dual Pak and Triple Pak From Phathom Pharmaceuticals, Inc
This month's clinical pharmacology update looks at a medication to manage Helicobacter pylori infection in adults.
Vtama Cream From Dermavant Sciences
Dartisla ODT From Edenbridge Pharmaceuticals
The FDA has approved glycopyrrolate orally disintegrating tablets (Dartisla ODT; Edenbridge Pharmaceuticals) to reduce symptoms of peptic ulcer as an adjunct to peptic ulcer treatment in adults.
Quviviq From Idorsia Pharmaceuticals
The FDA has approved daridorexant (Quviviq; Idorsia Pharmaceuticals, US Inc) to treat adults with insomnia.
Cibinqo From Pfizer Inc
The FDA has approved abrocitinib tablets to treat adults with moderate-to-severe, refractory atopic dermatitis.
Bijuva From TherapeuticsMD
TherapeuticsMD, Inc has submitted a supplemental New Drug Application for estradiol and progesterone capsules 0.5 mg/100 mg (Bijuva) to the FDA.
Vuity From Allergan
The FDA has approved pilocarpine hydrochloride ophthalmic solution 1.25% (Vuity, Allergan, an AbbVie company) to treat presbyopia in adults.1
Korsuva From Cara Therapeutics and Vifor Pharma
The FDA has approved Difelikefalin injection (Korsuva; Cara Therapeutics and Vifor Pharma) for the treatment of moderate-to-severe chronic kidney disease–associated pruritus in adults undergoing hemodialysis.
Qulipta From AbbVie
The FDA has approved atogepant oral tablets (Qulipta; AbbVie) for the preventive treatment of episodic migraines in adults.
Brukinsa From BeiGene, Ltd
The FDA has approved zanubrutinib (Brukinsa, BeiGene) for the treatment of adults with Waldenström macroglobulinemia (WM).
Saphnelo From AstraZeneca
The FDA approves anifrolumab-fnia injection (Saphnelo; AstraZeneca) for the treatment of adults with moderate to severe system- ic lupus erythematosus (SLE) who are receiving standard therapy.
Clinical Pharmacology Update: Kerendia From Bayer
Clinical Pharmacology Update: Brexafemme From Scynexis, Inc
Ponvory From Janssen Pharmaceuticals, Inc
Qelbree From Supernus Pharmaceuticals, Inc
The FDA has approved Qelbree (viloxazine extended-release capsules; Supernus Pharmaceuticals, Inc) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric patients aged 6 to 17 years.
Clinical Pharmacology Update: Evkeeza From Regeneron Pharmaceuticals, Inc
Evkeeza has been approved as an adjunct to other low-density lipoprotein cholesterol-lowering therapies to treat patients 12 years and older with homozygous familial hypercholesterolemia.
Clinical Pharmacology Update: Verquvo From Merck and Co, Inc
The FDA has approved Verquvo (vericiguat; Merck) tablets for adults with chronic heart failure.
Clinical Pharmacology Update: Gemtesa From Urovant Sciences
The FDA has approved Gemtesa (vibegron; Urovant Sciences) tablets to treat overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency.
Gavreto From Blueprint Medicines Corporation
RET fusions and mutations drive many types of cancer.
Eysuvis From Kala Pharmaceuticals, Inc
The FDA has approved Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease.
Inqovi From Astex Pharmaceuticals, Otsuka Pharmaceutical, and Taiho Oncology
Inqovi (decitabine and cedazuridine) tablets from Astex Pharmaceuticals, Otsuka Pharmaceutical, and Taiho Oncology are indicated to treat adults with myelodysplastic syndromes.
Rukobia From ViiV Healthcare
The FDA has approved Rukobia (fostemsavir) for the treatement of human immunodeficiency virus 1 (HIV-1) infection.
Ongentys From Neurocrine Biosciences Inc
As PD progresses, patients using levodopa/carbidopa may experience off-time episodes between medication doses, when the medication is not working and motor symptoms, such as difficulty walking, slowed movement, and tremor, return.
Barhemsys From Acacia Pharma
The FDA has approved Barhemsys (amisulpride) injection from Acacia Pharma for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults.
Nurtec ODT From Biohaven Pharmaceuticals, Inc
The FDA has approved Nurtec ODT (rimegepant) from Biohaven Pharmaceuticals to treat acute migraines with or without aura in adults.
Nexletol From Esperion Therapeutics, Inc
The FDA has approved Nexletol (bempedoic acid), a nonstatin cholesterol-lowering agent, in adults who require additional lowering of low-density lipoprotein cholesterol (LDL-C).
Caplyta From Intra-Cellular Therapies, Inc
Caplyta is an atypical antipsychotic and is thought to exert its effect through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
Palforzia From Aimmune Therapeutics Inc
Palforzia is an oral immunotherapy agent for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.
Talicia From RedHill Biopharma Ltd
The fda has approved talicia (amoxicillin, omeprazole magnesium, and rifabutin) for the treatment of Helicobacter pylori infection in adults.
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