FDA Approves Nexviazyme (avalglucosidase alfa-ngpt) for Late-Onset Pompe Disease
PARIS – August 6, 2021 -- The U.S. Food and Drug Administration (FDA) has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe
FDA Approves Saphnelo (anifrolumab) for Moderate to Severe Systemic Lupus Erythematosus
2 August 2021 -- AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving
FDA Approves Semglee (insulin glargine-yfgn) as the First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
SILVER SPRING, Md., July 28, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in a
FDA Approves Twyneo (tretinoin and benzoyl peroxide) for the Treatment of Acne Vulgaris
NESS ZIONA, Israel, July 27, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topica
FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)
BOSTON, July 20, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food & Drug Administration (
FDA Approves Fexinidazole as the First All-Oral Treatment for Sleeping Sickness
July 19, 2021 -- The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Huma
FDA Approves Rezurock (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)
NEW YORK, NY / ACCESSWIRE / July 16, 2021 / -- Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezurock™ (belumosudil) 200 mg once dai
FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults
KENILWORTH, N.J.--(BUSINESS WIRE) -- (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Vaxneuvance (Pneumococcal 15-v
FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes
WHIPPANY, N.J.-- July 9, 2021 (BUSINESS WIRE) -- Bayer announced today the United States (U.S.) Food and Drug Administration (FDA) has approved Kerendia (finerenone), a first-in-class nonsteroidal min
FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
DUBLIN, June 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombi
FDA Approves Verkazia (cyclosporine ophthalmic emulsion) for the Treatment of Vernal Keratoconjunctivitis
EMERYVILLE, Calif.--(BUSINESS WIRE) June 24, 2021 -- Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on eye care, today
FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use
WHIPPANY, N.J.--(BUSINESS WIRE) June 17, 2021 -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Astepro Allergy (Azelastine HCI .15%) as an over-the-counter (OTC)
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