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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

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