FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections
April 24, 2024 -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by su
FDA Grants Accelerated Approval for Ojemda (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma
BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing
FDA Approves Anktiva (nogapendekin alfa inbakicept-pmln) Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
CULVER CITY, Calif., April 22, 2024 -- ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved Anktiva (N-803, or noga
FDA Approves Lumisight (pegulicianine) Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomy
NEWTON, Mass.--(BUSINESS WIRE) April 18, 2024 -- Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection durin
FDA Approves Selarsdi (ustekinumab-aekn), a Biosimilar to Stelara
REYKJAVIK, Iceland & PARSIPPANY, N.J.--(BUSINESS WIRE) April 16, 2024 --Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TE
FDA Approves Zevtera (ceftobiprole medocaril sodium) for Bacteremia, Skin and Skin Structure Infections, and Pneumonia
Allschwil, Switzerland, April 04, 2024 -- Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacteria
FDA Approves Voydeya (danicopan) as Add-On Therapy for the Treatment of Extravascular Hemolysis in Paroxysmal Nocturnal Hemoglobinuria
April 1, 2024 -- Voydeya (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal h
FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia
Madrid -- 2 April, 2024 -- Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorised the marketing of Risvan®
FDA Approves Vafseo (vadadustat) for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis
CAMBRIDGE, Mass., March 27, 2024 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today
FDA Approves Winrevair (sotatercept-csrk) a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension
RAHWAY, N.J.--(BUSINESS WIRE) March 26, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved s
FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension
RARITAN, NJ, March 22, 2024 -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin r
FDA Approves Duvyzat (givinostat) for Duchenne Muscular Dystrophy
MILAN--(BUSINESS WIRE) -- Mar 22, 2024 -- Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inh
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