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 Anktiva (nogapendekin alfa inbakicept-pmln) Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Canceron April 22, 2024 at 3:04 am
CULVER CITY, Calif., April 22, 2024 -- ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus...
- U.S. FDA Approves Subcutaneous Administration of Takeda’s Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Diseaseon April 18, 2024 at 11:04 pm
OSAKA, Japan April 19, 2024 and CAMBRIDGE, Massachusetts, April 18, 2024 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Entyvio® (vedolizumab) subcutaneous (SC) administration for...
- FDA Approves Lumisight (pegulicianine) Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomyon April 18, 2024 at 10:04 pm
NEWTON, Mass.--(BUSINESS WIRE) April 18, 2024 --Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced the U.S. Food &...
- FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Canceron April 18, 2024 at 12:04 am
South San Francisco, CA -- April 18, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment...
- FDA Approves Selarsdi (ustekinumab-aekn), a Biosimilar to Stelaraon April 16, 2024 at 1:04 am
REYKJAVIK, Iceland & PARSIPPANY, N.J.--(BUSINESS WIRE) April 16, 2024 --Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug...
- 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+)...