Drugs.com - New Drug Approvals New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
- FDA Approves Lenmeldy (atidarsagene autotemcel) for Children with Metachromatic Leukodystrophyon March 18, 2024 at 7:03 pm
TOKYO and LONDON and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the U.S. Food and...
- Xhance Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polypson March 15, 2024 at 9:03 pm
YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has...
- FDA Grants Accelerated Approval for Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)on March 14, 2024 at 10:03 pm
CONSHOHOCKEN, Pa., March 14, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the U.S. Food and...
- FDA Approves Tevimbra (tislelizumab-jsgr) for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinomaon March 14, 2024 at 10:03 pm
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved...
- U.S. FDA Approves Bristol Myers Squibb’s Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)on March 14, 2024 at 12:03 am
PRINCETON, N.J.--(BUSINESS WIRE) Mar 14, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed...
- Mirum Pharmaceuticals’ Livmarli Receives FDA Approval for Treatment of Cholestatic Pruritus in Patients with Progressive Familial Intrahepatic Cholestasison March 13, 2024 at 12:03 am
FOSTER CITY, Calif.--(BUSINESS WIRE) March 13, 2024 -- Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved Livmarli® (maralixibat) oral solution for the treatment of...
- Praluent (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterolon March 11, 2024 at 8:03 pm
TARRYTOWN, N.Y., March 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other...
- Wegovy Approved in the US for Cardiovascular Risk Reduction in People with Overweight or Obesity and Established Cardiovascular Diseaseon March 8, 2024 at 9:03 pm
Bagsværd, Denmark, 8 March 2024 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy based on a supplemental New Drug Application (sNDA) for the indication of reducing...
- FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemraon March 7, 2024 at 11:03 pm
March 7, 2024 -- Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the United States (U.S.)...
- BeiGene Announces FDA Accelerated Approval of Brukinsa for the Treatment of Relapsed or Refractory Follicular Lymphomaon March 7, 2024 at 10:03 pm
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.-- Mar 07, 2024 (BUSINESS WIRE)-- BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted...
- U.S. Food and Drug Administration Approves Opdivo (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinomaon March 7, 2024 at 3:03 am
PRINCETON, N.J.--(BUSINESS WIRE) Mar 07, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line...
- FDA Approves Besponsa (inotuzumab ozogamicin) for Pediatric Patients with Acute Lymphoblastic Leukemiaon March 6, 2024 at 12:03 am
On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Efficacy was...
- FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgevaon March 5, 2024 at 6:03 pm
Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeable biosimilar to Xgeva. The FDA also...
- FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Proliaon March 5, 2024 at 8:03 am
Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Jubbonti, (denosumab-bbdz), an interchangeable biosimilar to Prolia. The FDA also...
- FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lineson March 4, 2024 at 10:03 pm
NEWPORT BEACH, Calif., March 4, 2024 /PRNewswire/ -- Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.) Food and Drug Administration (FDA) approval...
- Lantheus Announces the FDA Approval of Definity (Perflutren Lipid Microsphere) for Pediatric Patientson March 4, 2024 at 3:03 am
BEDFORD, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow® disease to deliver...
- Rybrevant (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutationson March 1, 2024 at 1:03 am
RARITAN, New Jersey (March 01, 2024) – Johnson & Johnson (NYSE: JNJ) announced today that following a priority review, the U.S. Food and Drug Administration (FDA) has approved Rybrevant® (amivantamab-vmjw) in combination with...
- FDA Approves Exblifep (cefepime/enmetazobactam) for the Treatment of Complicated Urinary Tract Infectionson February 27, 2024 at 6:02 pm
SAINT-LOUIS, France & WEILL AM RHEIN, Germany February 27, 2024 -- Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug...
- U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy to Treat People with HIV with Suppressed Viral Loads, Pre-Existing Resistanceon February 26, 2024 at 1:02 am
FOSTER CITY, Calif.--(BUSINESS WIRE) February 26, 2024 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200...
- Johnson & Johnson Announces Expansion of Imbruvica (ibrutinib) Label in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indicationson February 26, 2024 at 1:02 am
HORSHAM, PA. February 26, 2024 – Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for...