Drugs.com - New Drug Approvals

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

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...

FDA Approves Attruby (acoramidis) to Reduce Cardiovascular Death and Cardiovascular-Related Hospitalization in Patients with ATTR-CM

FDA Approves Attruby (acoramidis) to Reduce Cardiovascu...

Feb 9, 2025 0

PALO ALTO, Calif., Nov. 22, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasd...

FDA Approves Simplified Dosing Regimen for Acetadote (N-acetylcysteine for injection)

FDA Approves Simplified Dosing Regimen for Acetadote (N...

Feb 9, 2025 0

NASHVILLE, Tenn., Dec. 9, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (...

Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del Trikafta-Responsive Variants

Vertex Announces U.S. FDA Approval for Trikafta (elexac...

Feb 9, 2025 0

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

FDA Approves Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) Subcutaneous Injection for Use in Most Previously Approved Solid Tumor Opdivo (nivolumab) Indications

FDA Approves Opdivo Qvantig (nivolumab and hyaluronidas...

Feb 9, 2025 0

PRINCETON, N.J.--(BUSINESS WIRE) December 27, 2024 -- Bristol Myers Squibb (NYS...

FDA Approves Onapgo (apomorphine hydrochloride) for the Treatment of Motor Fluctuations in Adults with Advanced Parkinson’s Disease

FDA Approves Onapgo (apomorphine hydrochloride) for the...

Feb 9, 2025 0

ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc....

FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Treatment of Diabetic Macular Edema

FDA Approves Genentech’s Susvimo as the First and Only ...

Feb 9, 2025 0

South San Francisco, CA -- February 4, 2025 -- Genentech, a member of the Roche ...

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