Biopharma

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...

FDA Approves Symvess (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma

FDA Approves Symvess (acellular tissue engineered vesse...

Feb 9, 2025 0

DURHAM, N.C., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a...

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

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 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 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 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...

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...

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...

Datopotamab Deruxtecan Granted Priority Review in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Datopotamab Deruxtecan Granted Priority Review in the U...

Feb 9, 2025 0

13 January 2025 -- AstraZeneca and Daiichi Sankyo’s Biologics License Applicatio...

$GSK’s B7-H3-Targeted Antibody-Drug Conjugate, GSK’227, Receives US FDA Breakthrough Therapy Designation in Late-Line Relapsed or Refractory Osteosarcoma$

GSK’s B7-H3-Targeted Antibody-Drug Conjugate, GSK’227, ...

Feb 9, 2025 0

London, UK January 07 2025 -- GSK plc (LSE/NYSE: GSK) announced today that the U...

Alterity Therapeutics Announces Positive ATH434 Phase 2 Trial Results in Multiple System Atrophy Led By Robust Clinical Efficacy

Alterity Therapeutics Announces Positive ATH434 Phase 2...

Feb 9, 2025 0

MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – 30 January 2025: Alterity Therape...

Zydus Announces USFDA Orphan Drug Designation to Usnoflast for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Zydus Announces USFDA Orphan Drug Designation to Usnofl...

Feb 9, 2025 0

Ahmedabad, India, January 22, 2025 Zydus, a leading, discovery-based, global pha...

Adaptimmune Announces U.S. FDA Breakthrough Therapy Designation Granted to Letetresgene Autoleucel (lete-cel) for Treatment of Myxoid/Round Cell Liposarcoma (MRCLS)

Adaptimmune Announces U.S. FDA Breakthrough Therapy Des...

Feb 9, 2025 0

Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - January...

Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Merck Announces Phase 3 waveLINE-010 Trial Initiation E...

Feb 9, 2025 0

RAHWAY, N.J.--(BUSINESS WIRE) February 6, 2025 -- Merck (NYSE: MRK), known as M...

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