Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine Spikevax
Approval based on a comprehensive submission package including efficacy and safety data approximately six months after second dose Spikevax has received approval by regulators in more than 70 countrie
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
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