- FDA Approves Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) Subcutaneous Injection for Use in Most Previously Approved Solid Tumor Opdivo (nivolumab) Indications
PRINCETON, N.J.--(BUSINESS WIRE) December 27, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for...
- Tevimbra Approved in U.S. for First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with Chemotherapy
SAN MATEO, Calif.--(BUSINESS WIRE)-- December 27, 2024 -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced the U.S. Food and Drug...
- Sumitomo Pharma America Announces U.S. FDA Approval of Gemtesa (vibegron) for Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia
MARLBOROUGH, Mass., Dec. 23, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) announced today that the U.S. Food and Drug Administration (FDA) has approved Gemtesa (vibegron), a beta-3 (β3) adrenergic receptor agonist, dosed once-daily...
- FDA Approves Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the Treatment of Cystic Fibrosis
BOSTON--(BUSINESS WIRE)--Dec. 20, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class...
- U.S. FDA Approves Pfizer’s Braftovi Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
NEW YORK--(BUSINESS WIRE) December 20, 2024 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux® ) and mFOLFOX6...
- 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...
- Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del Trikafta-Responsive Variants
BOSTON--(BUSINESS WIRE)--Dec. 20, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for...
- FDA Approves Alhemo (concizumab-mtci) to Prevent or Reduce Bleeding Episodes in People with Hemophilia A or B with Inhibitors
PLAINSBORO, N.J., Dec. 20, 2024 /PRNewswire/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding...
- Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Patients as Young as 2 Years Old
BOSTON, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S...
- 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...
- FDA Approves Symvess (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma
DURHAM, N.C., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug...
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...