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.
- Fasenra Approved for Treatment of Children Aged 6 to 11 with Severe Asthmaon April 11, 2024 at 10:04 pm
WILMINGTON, Del.--(BUSINESS WIRE) April 11, 2024 --AstraZeneca’s Fasenra® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an...
- Xcopri (cenobamate) Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric Tubeon April 11, 2024 at 9:04 pm
PARAMUS, N.J., April 11, 2024 /PRNewswire/ -- SK Life Science, Inc., a U.S. pharmaceutical company developing treatments that will change the future of central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals, Co., Ltd.,...
- ViiV Healthcare Announces U.S. FDA Approval of Dovato (dolutegravir/lamivudine) for Adolescents Living with HIVon April 8, 2024 at 10:04 pm
Durham, NC, April 8, 2024 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato...
- Enhertu Approved in the US as First Tumor-Agnostic HER2-Directed Therapy for Previously Treated Patients with Metastatic HER2-Positive Solid Tumorson April 6, 2024 at 1:04 am
April 6, 2024 -- AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic...
- FDA Approves Carvykti for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapyon April 5, 2024 at 2:04 am
HORSHAM, PA (April 5, 2024) – Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved Carvykti® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with...
- U.S. FDA Approves Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapyon April 5, 2024 at 1:04 am
PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE) April 05, 2024 -- Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma®...
- FDA Approves Zevtera (ceftobiprole medocaril sodium) for Bacteremia, Skin and Skin Structure Infections, and Pneumoniaon April 4, 2024 at 1:04 am
Allschwil, Switzerland, April 04, 2024 -- Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the...
- Vanda Pharmaceuticals' Fanapt (iloperidone) Receives U.S. FDA Approval for the Acute Treatment of Bipolar I Disorderon April 2, 2024 at 5:04 am
WASHINGTON, April 2, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes...
- FDA Approves Risvan (risperidone) for the Treatment of Schizophreniaon April 2, 2024 at 3:04 am
Madrid – 2 April, 2024 – Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorised the marketing of Risvan®...
- FDA Approves Voydeya (danicopan) as Add-On Therapy for the Treatment of Extravascular Hemolysis in Paroxysmal Nocturnal Hemoglobinuriaon April 1, 2024 at 10:04 pm
April 1, 2024 -- Voydeya (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).1 Voydeya is a...
- FDA Expands Indication for Gilead's Vemlidy (tenofovir alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Sixon March 28, 2024 at 11:03 pm
March 28, 2024 -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir...
- FDA Approves Vafseo (vadadustat) for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysison March 27, 2024 at 7:03 pm
CAMBRIDGE, Mass., March 27, 2024 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug...
- FDA Approves Winrevair (sotatercept-csrk) a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertensionon March 26, 2024 at 10:03 pm
RAHWAY, N.J.--(BUSINESS WIRE) March 26, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name:...
- FDA Approves Medexus's Supplemental Biologics License Application for Ixinity to Treat Hemophilia B in Pediatric Patientson March 26, 2024 at 9:03 pm
Toronto, Ontario and Chicago, Illinois-- March 26, 2024 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus's supplemental Biologics License Application (sBLA)...
- Ultomiris Approved in the US for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder (NMOSD)on March 25, 2024 at 7:03 pm
25 March 2024 -- Ultomiris (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+)...
- FDA Approves Duvyzat (givinostat) for Duchenne Muscular Dystrophyon March 22, 2024 at 7:03 pm
MILAN--(BUSINESS WIRE)-- Mar 22, 2024 -- Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6...
- FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertensionon March 22, 2024 at 7:03 pm
RARITAN, NJ, March 22, 2024 – Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and...
- U.S. Food and Drug Administration (FDA) Grants Full Approval for Elahere (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patientson March 22, 2024 at 7:03 pm
The full approval of Elahere is based on the confirmatory MIRASOL Phase 3 trial that supports the medicine as a potential new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC) Data show that...
- U.S. FDA Approves Broad New Labels for Nexletol and Nexlizet to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Useon March 22, 2024 at 7:03 pm
ANN ARBOR, Mich., March 22, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for Nexletol (bempedoic acid) Tablets and Nexlizet...
- FDA Approves Tryvio (aprocitentan) for the Combination Treatment of Resistant Hypertensionon March 20, 2024 at 11:03 pm
RADNOR, Pa., March 20, 2024 /PRNewswire/ -- Idorsia Pharmaceuticals U.S. Inc. announced today that the US Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other...
