AATP Interactive

Drug Approvals

FDA Approves Zepbound (tirzepatide) as the First and Only Prescription Medicine for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity
INDIANAPOLIS, Dec. 20, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Zepbound (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe...
View Pub Date: Fri, 20 Dec 2024 02:12:06 +0000

FDA Approves Tryngolza (olezarsen) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome
CARLSBAD, Calif., Dec. 19, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults...
View Pub Date: Thu, 19 Dec 2024 02:12:37 +0000

FDA Approves Ryoncil (remestemcel-L-rknd) Mesenchymal Stromal Cell Therapy for Steroid-Refractory Acute Graft Versus Host Disease
NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the Food and Drug Administration (FDA) approved Ryoncil (remestemcel-L)...
View Pub Date: Wed, 18 Dec 2024 23:12:47 +0000

FDA Approves Ensacove (ensartinib) for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who...
View Pub Date: Wed, 18 Dec 2024 00:12:55 +0000

FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to Stelara
JERSEY CITY, N.J., Dec. 17, 2024 -- Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for subcutaneous injection or intravenous infusion in...
View Pub Date: Tue, 17 Dec 2024 06:12:47 +0000

FDA Approves Vtama (tapinarof) Cream for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older
JERSEY CITY, N.J.--(BUSINESS WIRE) December 16, 2024 -- Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) has...
View Pub Date: Mon, 16 Dec 2024 20:12:32 +0000

Galderma Receives U.S. FDA Approval for Nemluvio (nemolizumab) for Patients with Moderate-to-Severe Atopic Dermatitis
Zug, Switzerland – December 13, 2024 – Galderma today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nemluvio (nemolizumab) for the treatment of patients 12 years and older with moderate-to-severe...
View Pub Date: Sun, 15 Dec 2024 22:12:17 +0000

FDA Approves Crenessity (crinecerfont) for the Treatment of Children and Adults with Classic Congenital Adrenal Hyperplasia
SAN DIEGO, Dec. 13, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved Crenessity (crinecerfont) capsules and oral solution as an adjunctive treatment to glucocorticoid...
View Pub Date: Sun, 15 Dec 2024 20:12:54 +0000

FDA Approves Unloxcyt (cosibelimab-ipdl) for the Treatment of Cutaneous Squamous Cell Carcinoma
WALTHAM, Mass., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration ("FDA") has approved Unloxcyt (cosibelimab-ipdl) for the treatment of adults...
View Pub Date: Fri, 13 Dec 2024 21:12:54 +0000

FDA Approves Simplified Dosing Regimen for Acetadote (N-acetylcysteine for injection)
NASHVILLE, Tenn., Dec. 9, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on delivering high-quality products to improve patient care, announced today the FDA has approved a...
View Pub Date: Mon, 09 Dec 2024 03:12:40 +0000

Imfinzi Approved in the US as First and Only Immunotherapy Regimen for Patients with Limited-Stage Small Cell Lung Cancer
5 December 2024 -- AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based...
View Pub Date: Thu, 05 Dec 2024 22:12:03 +0000

FDA Grants Accelerated Approval to Bizengri (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) [Merus, the Company, we, or our], a clinical-stage oncology company developing innovative, full-length, multispecific antibodies (Biclonics...
View Pub Date: Wed, 04 Dec 2024 23:12:59 +0000

FDA Approves Yesintek (ustekinumab-kfce), a Biosimilar to Stelara
Bengaluru, Karnataka, India, December 01, 2024 -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the U.S. Food and Drug Administration...
View Pub Date: Sun, 01 Dec 2024 23:12:30 +0000

FDA Approves Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting
Vienna, -- November 27th 2024 -- AOP Orphan Pharmaceuticals GmbH (AOP Health), based in Vienna, Austria, announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for Rapiblyk (landiolol) in the hospital critical...
View Pub Date: Wed, 27 Nov 2024 19:11:35 +0000

FDA Approves Imkeldi (imatinib) Oral Solution for the Treatment of Certain Forms of Leukemia and Other Cancers
CAMBRIDGE, Mass.-- November 25, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the FDA has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to...
View Pub Date: Mon, 25 Nov 2024 21:11:51 +0000

FDA Approves Attruby (acoramidis) to Reduce Cardiovascular Death and Cardiovascular-Related Hospitalization in Patients with ATTR-CM
PALO ALTO, Calif., Nov. 22, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a new type of biopharmaceutical company focused on genetic diseases, today announced that the U.S. Food and Drug...
View Pub Date: Fri, 22 Nov 2024 22:11:10 +0000

FDA Grants Accelerated Approval to Ziihera (zanidatamab-hrii) for the Treatment of HER2-Positive Biliary Tract Cancer
DUBLIN, Nov. 20, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the...
View Pub Date: Wed, 20 Nov 2024 02:11:05 +0000

UCB Receives U.S. FDA Approval for Bimzelx (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate to Severe Hidradenitis Suppurativa
Brussels (Belgium), November 20, 2024 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults...
View Pub Date: Wed, 20 Nov 2024 01:11:59 +0000

FDA Approves Revuforj (revumenib) for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation
WALTHAM, Mass., Nov. 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj (revumenib) as the first and only menin inhibitor for the treatment of...
View Pub Date: Fri, 15 Nov 2024 00:11:44 +0000

FDA Approves Danziten (nilotinib) Tablets, the First and Only Nilotinib With No Mealtime Restrictions
WOBURN, Mass. Nov 14, 2024 – Azurity Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly...
View Pub Date: Thu, 14 Nov 2024 01:11:12 +0000

FDA Approves Kebilidi (eladocagene exuparvovec-tneq) Gene Therapy for the Treatment of AADC Deficiency
WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy...
View Pub Date: Wed, 13 Nov 2024 02:11:31 +0000

FDA Approves Aucatzyl (obecabtagene autoleucel) for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the U.S. Food and Drug Administration...
View Pub Date: Fri, 08 Nov 2024 21:11:15 +0000

FDA Approves Emrosi (minocycline hydrochloride) for the Treatment of Rosacea
SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug...
View Pub Date: Mon, 04 Nov 2024 00:11:22 +0000

Shorla Oncology Announces U.S. FDA Expanded Approval of Jylamvo (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indications
CAMBRIDGE, Mass.--(BUSINESS WIRE) October 29, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has expanded the approval of Jylamvo...
View Pub Date: Tue, 29 Oct 2024 10:10:59 +0000

Novartis Scemblix Granted FDA Accelerated Approval in Newly Diagnosed CML
East Hanover, October 29, 2024 – Novartis announced today that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic...
View Pub Date: Tue, 29 Oct 2024 10:10:44 +0000