New Drug Approvals

New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

FDA Approves Veklury (remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression

January 20 2022

Approval Based on Phase 3 Data Showing Veklury Significantly Reduced Risk of Hospitalization By 87% Compared with Placebo NIH Guidelines Recommend Veklury for the Treatment of Non-Hospitalized Patients at High Risk FDA Expands Pediatric...

FDA Approves Ryaltris (mometasone and olopatadine) Nasal Spray for Seasonal Allergic Rhinitis

January 14 2022

Mumbai (Maharashtra) [India], January 14, 2022 (ANI/PRNewswire) -- Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company announced that its fully owned subsidiary Glenmark Specialty S.A. (Switzerland), received...

FDA Approves Cibinqo (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis

January 14 2022

NEW YORK--(BUSINESS WIRE) January 14, 2022 -- Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the...

FDA Approves Quviviq (daridorexant) for the Treatment of Adults with Insomnia

January 10 2022

Allschwil, Switzerland – January 10, 2022 Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has approved Quviviq (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia,...

FDA Approves Recorlev (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome

December 30 2021

CHICAGO--(BUSINESS WIRE)--Dec. 30, 2021-- Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, today...

FDA Approves Adbry (tralokinumab-ldrm) for Adults with Moderate-to-Severe Atopic Dermatitis

December 28 2021

MADISON, N.J.--(BUSINESS WIRE) December 28, 2021 --LEO Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Adbry™ (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18...