FDA Approves Releuko (filgrastim-ayow), a Biosimilar to Neupogen
February 28, 2022 -- The United States (U.S.) Food and Drug Administration (FDA) has approved Releuko (filgrastim-ayow), a biosimilar to Neupogen (filgrastim). The FDA approval was based on a review o
FDA Approves Norliqva (amlodipine) Oral Solution for Hypertension and Coronary Artery Disease
February 28, 2022 -- The U.S. Food and Drug Administration has approved Norliqva (amlodipine) oral solution for the treatment of: Hypertension in adults and children 6 years and older, to lower blood
FDA Approves NephroScan (Kit for the Preparation of Technetium Tc 99m Succimer Injection) for Radiodiagnostic Imaging
LONDON, UK, 21 February 2022 -- Theragnostics announces that NephroScan, its radiodiagnostic imaging drug used as an aid for the evaluation of renal parenchymal disorders in adult and pediatric patien
FDA Approves Pyrukynd (mitapivat) as First Disease-Modifying Therapy for Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency
CAMBRIDGE, Mass., Feb. 17, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, toda
FDA Approves Enjaymo (sutimlimab-jome) for Use in Patients with Cold Agglutinin Disease
Paris, February 4, 2022. -- The U.S. Food and Drug Administration (FDA) has approved Enjaymo™ (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold
FDA Approves Fleqsuvy (baclofen oral suspension) for the Treatment of Spasticity
WOBURN, MA, February 7, 2022 -- Azurity Pharmaceuticals, Inc., a private specialty pharmaceutical company, focused on developing innovative products to meet the unique needs of patients with underserv
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
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