NDA News-CliniExpert

FDA Approves Vabysmo (faricimab-svoa) for the Treatment of Neovascular (Wet) Age-Related Macular Degeneration and Diabetic Macular Edema

South San Francisco, CA -- January 28, 2022 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Vabysm

FDA Approves Kimmtrak (tebentafusp-tebn) for the Treatment of Unresectable or Metastatic Uveal Melanoma

Kimmtrak is the first and only FDA approved therapy for the treatment of unresectable or metastatic uveal melanoma (mUM) Kimmtrak is the first T cell receptor (TCR) therapeutic to receive regulatory a

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

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

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

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-da

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

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 treatmen

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

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

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

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 modera

FDA Approves Leqvio (inclisiran), First-in-Class siRNA to Reduce Low-Density Lipoprotein Cholesterol (LDL-C)

With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction(1) Leqvio provides effective and sustained LDL-

FDA Approves Apretude (cabotegravir extended-release injectable suspension) for HIV Pre-Exposure Prophylaxis (PrEP)

LONDON--(BUSINESS WIRE) December 20, 2021 -- ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) a

FDA Approves Vyvgart (efgartigimod alfa-fcab) for the Treatment of Generalized Myasthenia Gravis

Breda, the Netherlands—Dec. 17, 2021 -- argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and ca

FDA Approves Tezspire (tezepelumab) for Severe Asthma

17 December 2021 -- AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with s

FDA Approves Yusimry (adalimumab-aqvh), a Biosimilar to Humira

REDWOOD CITY, Calif., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) appro