Drugs.com - New Drug Approvals

U.S. FDA Approves Expanded Label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for Geographic Atrophy

U.S. FDA Approves Expanded Label for Astellas' Izervay ...

Feb 13, 2025 0

TOKYO, Feb. 12, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President ...

$U.S. FDA Approves Pfizer’s Adcetris Combination Regimen for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma$

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

Feb 13, 2025 0

NEW YORK--(BUSINESS WIRE) February 12, 2025 -- Pfizer Inc. (NYSE: PFE) announced...

FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)

FDA Approves Genentech’s Evrysdi Tablet as First and On...

Feb 13, 2025 0

South San Francisco, CA -- February 12, 2025 -- Genentech, a member of the Roche...

FDA Approves Gomekli (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN

FDA Approves Gomekli (mirdametinib) for the Treatment o...

Feb 12, 2025 0

STAMFORD, Conn., Feb. 11, 2025 -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX),...

FDA Approves Emblaveo (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections

FDA Approves Emblaveo (aztreonam and avibactam) for the...

Feb 10, 2025 0

NORTH CHICAGO, Ill., Feb. 7, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today anno...

FDA Approves Emblaveo (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options

FDA Approves Emblaveo (aztreonam and avibactam) for the...

Feb 10, 2025 0

NORTH CHICAGO, Ill., Feb. 7, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today anno...

FDA Approves Vtama (tapinarof) Cream for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

FDA Approves Vtama (tapinarof) Cream for the Treatment ...

Feb 9, 2025 0

JERSEY CITY, N.J.--(BUSINESS WIRE) December 16, 2024 -- Organon (NYSE: OGN), a ...

Galderma Receives U.S. FDA Approval for Nemluvio (nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis

Galderma Receives U.S. FDA Approval for Nemluvio (nemol...

Feb 9, 2025 0

Zug, Switzerland – December 13, 2024 – Galderma today announced that the United ...

FDA Approves Crenessity (crinecerfont) for the Treatment of Children and Adults with Classic Congenital Adrenal Hyperplasia

FDA Approves Crenessity (crinecerfont) for the Treatmen...

Feb 9, 2025 0

SAN DIEGO, Dec. 13, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: N...

FDA Approves Unloxcyt (cosibelimab-ipdl) for the Treatment of Cutaneous Squamous Cell Carcinoma

FDA Approves Unloxcyt (cosibelimab-ipdl) for the Treatm...

Feb 9, 2025 0

WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ...

Imfinzi Approved in the US as First and Only Immunotherapy Regimen for Patients with Limited-Stage Small Cell Lung Cancer

Imfinzi Approved in the US as First and Only Immunother...

Feb 9, 2025 0

5 December 2024 -- AstraZeneca’s Imfinzi (durvalumab) has been approved in the U...

FDA Grants Accelerated Approval to Bizengri (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer

FDA Grants Accelerated Approval to Bizengri (zenocutuzu...

Feb 9, 2025 0

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 04, 2024 (GLOBE NEWSWIRE) --...

FDA Approves Yesintek (ustekinumab-kfce), a Biosimilar to Stelara

FDA Approves Yesintek (ustekinumab-kfce), a Biosimilar ...

Feb 9, 2025 0

Bengaluru, Karnataka, India, December 01, 2024 -- Biocon Biologics Ltd (BBL), a ...

FDA Approves Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting

FDA Approves Rapiblyk (landiolol) for Atrial Fibrillati...

Feb 9, 2025 0

Vienna, -- November 27th 2024 -- AOP Orphan Pharmaceuticals GmbH (AOP Health), b...

FDA Approves Imkeldi (imatinib) Oral Solution for the Treatment of Certain Forms of Leukemia and Other Cancers

FDA Approves Imkeldi (imatinib) Oral Solution for the T...

Feb 9, 2025 0

CAMBRIDGE, Mass.-- November 25, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Irelan...

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:...

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. ...

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...

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 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...

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...

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 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...

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