CLINICAL ROLE -
Zurzuvae From Sage Therapeutics
Read More
Velsipity From Pfizer
Exxua From Fabre-Kramer Pharmaceuticals
Litfulo From Pfizer Inc
The approval carries the limitation that ritlecitinib should not be used in combination with biologic immunomodulators, cyclosporine, other Janus kinase inhibitors, or other potent immunosuppressants.
Prescription: Beyfortus From Sanofi Pasteur, Inc
Inpefa From Lexicon Pharmaceuticals, Inc.
Veozah From Astellas Pharma
Zavzpret From Pfizer
Brenzavvy From TheracosBio
The approval carries the limitation that bexagliflozin may increase the risk of diabetic ketoacidosis in patients with type 1 diabetes.
Leqembi From Eisai
Leqembi is an intravenous injection for the treatment of Alzheimer disease.
Krazati From Mirati Therapeutics
Adagrasib is a RAS GTPase family inhibitor with objective response rate in patients with certain types of locally advanced or metastatic non–small cell lung cancer (NSCLC).
Tzield From Provention Bio, Inc
Tzield does not have any known contraindications.
Rolvedon From Spectrum Pharmaceuticals, Inc
Eflapegrastim-xnst subcutaneous injection (Rolvedon) reduces infections related to febrile neutropenia in adults with nonmyeloid malignant tumors who are being treated with certain anticancer drugs.
Sotyktu From Bristol Myers Squibb
The drug is indicated for moderate to severe plaque psoriasis.
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.