Drugs.com - New Drug Approvals

FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to Stelara

FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar ...

Feb 9, 2025 0

JERSEY CITY, N.J., Dec. 17, 2024 -- Celltrion announced today that the U.S. Food...

FDA Approves Ensacove (ensartinib) for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

FDA Approves Ensacove (ensartinib) for ALK-Positive Loc...

Feb 9, 2025 0

On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensa...

$FDA Approves Ryoncil (remestemcel-L-rknd) Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft Versus Host Disease$

FDA Approves Ryoncil (remestemcel-L-rknd) Mesenchymal S...

Feb 9, 2025 0

NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:...

FDA Approves Tryngolza (olezarsen) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome

FDA Approves Tryngolza (olezarsen) to Reduce Triglyceri...

Feb 9, 2025 0

CARLSBAD, Calif., Dec. 19, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nas...

Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Patients as Young as 2 Years Old

Rhythm Pharmaceuticals Announces FDA Approval of Imcivr...

Feb 9, 2025 0

BOSTON, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: ...

FDA Approves Alhemo (concizumab-mtci) to Prevent or Reduce Bleeding Episodes in People with Hemophilia A or B with Inhibitors

FDA Approves Alhemo (concizumab-mtci) to Prevent or Red...

Feb 9, 2025 0

PLAINSBORO, N.J., Dec. 20, 2024 /PRNewswire/ -- Novo Nordisk announced today tha...

FDA Approves Zepbound (tirzepatide) as the First and Only Prescription Medicine for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity

FDA Approves Zepbound (tirzepatide) as the First and On...

Feb 9, 2025 0

INDIANAPOLIS, Dec. 20, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) to...

U.S. FDA Approves Pfizer’s Braftovi Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer

U.S. FDA Approves Pfizer’s Braftovi Combination Regimen...

Feb 9, 2025 0

NEW YORK--(BUSINESS WIRE) December 20, 2024 -- Pfizer Inc. (NYSE: PFE) today ann...

FDA Approves Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the Treatment of Cystic Fibrosis

FDA Approves Alyftrek (vanzacaftor/tezacaftor/deutivaca...

Feb 9, 2025 0

BOSTON--(BUSINESS WIRE)--Dec. 20, 2024-- Vertex Pharmaceuticals Incorporated (Na...

Sumitomo Pharma America Announces U.S. FDA Approval of Gemtesa (vibegron) for Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia

Sumitomo Pharma America Announces U.S. FDA Approval of ...

Feb 9, 2025 0

MARLBOROUGH, Mass., Dec. 23, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. ...

Tevimbra Approved in U.S. for First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with Chemotherapy

Tevimbra Approved in U.S. for First-line Treatment of G...

Feb 9, 2025 0

SAN MATEO, Calif.--(BUSINESS WIRE)-- December 27, 2024 -- BeiGene, Ltd. (NASDAQ:...

FDA Approves Datroway (datopotamab deruxtecan-dlnk) for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

FDA Approves Datroway (datopotamab deruxtecan-dlnk) for...

Feb 9, 2025 0

WILMINGTON, Del.-- January 17, 2025 -- Datroway (datopotamab deruxtecan-dlnk) ha...

FDA Approves Symbravo (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults

FDA Approves Symbravo (meloxicam and rizatriptan) for t...

Feb 9, 2025 0

NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: A...

FDA Approves Avtozma (tocilizumab-anoh), a Biosimilar to Actemra

FDA Approves Avtozma (tocilizumab-anoh), a Biosimilar t...

Feb 9, 2025 0

JERSEY CITY, N.J., Jan. 30, 2025 -- Celltrion today announced that the U.S. Food...

FDA Approves Journavx (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain

FDA Approves Journavx (suzetrigine), a First-in-Class T...

Feb 9, 2025 0

BOSTON--(BUSINESS WIRE)--Jan. 30, 2025-- Vertex Pharmaceuticals Incorporated (Na...

FDA Approves Ozempic (semaglutide) as the Only GLP-1 RA to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults with Type 2 Diabetes and Chronic Kidney Disease

FDA Approves Ozempic (semaglutide) as the Only GLP-1 RA...

Feb 9, 2025 0

PLAINSBORO, N.J., Jan. 28, 2025 /PRNewswire/ -- Novo Nordisk today announced tha...

Enhertu Approved as First HER2-Directed Therapy for Patients with HER2-Low or HER2-Ultralow Metastatic Breast Cancer

Enhertu Approved as First HER2-Directed Therapy for Pat...

Feb 9, 2025 0

27 January 2025 -- AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxte...

FDA Approves Leqembi (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease

FDA Approves Leqembi (lecanemab-irmb) IV Maintenance Do...

Feb 9, 2025 0

TOKYO and CAMBRIDGE, Mass., January 27, 2025 – Eisai Co., Ltd. (Headquarters: To...

FDA Approves Grafapex (treosulfan) Preparative Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

FDA Approves Grafapex (treosulfan) Preparative Regimen ...

Feb 9, 2025 0

On January 22, 2025, Medexus was informed that the FDA approved Grafapex, an alk...

Spravato (esketamine) Approved in the U.S. as the First and Only Monotherapy for Adults with Treatment-Resistant Depression

Spravato (esketamine) Approved in the U.S. as the First...

Feb 9, 2025 0

Titusville, New Jersey, January 21, 2025 – Johnson & Johnson (NYSE: JNJ) announc...

Calquence Plus Chemoimmunotherapy Approved in the U.S. for Patients with Previously Untreated Mantle Cell Lymphoma

Calquence Plus Chemoimmunotherapy Approved in the U.S. ...

Feb 9, 2025 0

17 January 2025 -- AstraZeneca’s Calquence (acalabrutinib) in combination with b...

$FDA Approves Lumakras (sotorasib) in Combination with Vectibix (panitumumab) for Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer$

FDA Approves Lumakras (sotorasib) in Combination with V...

Feb 9, 2025 0

THOUSAND OAKS, Calif., Jan. 17, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today a...

FDA Approves Lilly's Omvoh (mirikizumab-mrkz) for Crohn's Disease, Expanding Its Use to the Second Major Type of Inflammatory Bowel Disease

FDA Approves Lilly's Omvoh (mirikizumab-mrkz) for Crohn...

Feb 9, 2025 0

INDIANAPOLIS, Jan. 15, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) an...

Incyte and Syndax Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo (axatilimab-csfr) 9 mg and 22 mg Vial Sizes

Incyte and Syndax Announce U.S. Food and Drug Administr...

Feb 9, 2025 0

WILMINGTON, Del. and WALTHAM, Mass., Jan. 15, 2025 /PRNewswire/ -- Incyte (Nasda...

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