FDA Approves Omisirge (omidubicel-onlv) Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation
BOSTON--(BUSINESS WIRE)--Apr. 17, 2023-- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved Gamida Cell’s... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves RizaFilm (rizatriptan) Oral Film for the Treatment of Acute Migraine
SAINT LAURENT, Quebec, April 17, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the " Company " or " IntelGenx " ), a leader in pharmaceutical films, today announced that the U.S. Food and Drug Administration (“FDA”) has... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 17, 2023 Category: Drugs & Pharmacology Source Type: news
Horizon Therapeutics plc Announces FDA Approval of an Update to the Indication Language for Tepezza (teprotumumab-trbw) to Specify its Use in Thyroid Eye Disease (TED) Patients Regardless of Disease Activity or Duration
DUBLIN--(BUSINESS WIRE)--Apr. 14, 2023-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Indications and Usage section of the Tepezza label to specify its use for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 14, 2023 Category: Drugs & Pharmacology Source Type: news
Takeda Receives FDA Approval to Expand the Use of Hyqvia to Treat Primary Immunodeficiency in Children
CAMBRIDGE, Mass.--(BUSINESS WIRE) April 11, 2023 --Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) to expand the use of Hyqvia to treat... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 11, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Merck ’s Keytruda (pembrolizumab) in Combination With Padcev (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
RAHWAY, N.J.--(BUSINESS WIRE) April 3, 2023 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 3, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Over-the-Counter Designation for Emergent BioSolutions ’ Narcan Nasal Spray, a Historic Milestone for the Opioid Overdose Emergency Treatment
GAITHERSBURG, Md., March 29, 2023 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved Narcan® Naloxone HCl Nasal Spray 4 mg as an over-the-counter (OTC)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 29, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Converts to Full Approval Indication for Keytruda (pembrolizumab) for Certain Adult and Pediatric Patients With Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors
RAHWAY, N.J.--(BUSINESS WIRE) March 29, 2023 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Keytruda, Merck’s anti-PD-1... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 29, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Joenja (leniolisib) for the Treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)
LEIDEN, The Netherlands, March 24, 2023 /PRNewswire/ -- Pharming Group N.V. ( " Pharming " or " the Company " ) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the US Food and Drug Administration (FDA) has approved Joenja® (leniolisib) for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 26, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Rezzayo (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis
SAN DIEGO& PARSIPPANY, N.J.--(BUSINESS WIRE)-- March 22, 2023 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved Rezzayo (rezafungin for injection)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 23, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)
WILMINGTON, Del.--(BUSINESS WIRE)--Mar. 22, 2023-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz™ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves First-in-class Evkeeza (evinacumab-dgnb) for Young Children with Ultra-Rare Form of High Cholesterol
TARRYTOWN, N.Y., March 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza (evinacumab-dgnb) as an adjunct to other... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 22, 2023 Category: Drugs & Pharmacology Source Type: news
Sandoz Receives US FDA Approval for Biosimilar Hyrimoz (adalimumab-adaz) High-Concentration Formulation
Biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®*
With this approval, Sandoz adalimumab HCF biosimilar will offer US patients reduced injection volume... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 21, 2023 Category: Drugs & Pharmacology Source Type: news
Novartis Tafinlar + Mekinist Approved by FDA for Pediatric Patients with BRAF V600E Low-Grade Glioma
New approval based on TADPOLE trial showing overall response rate (ORR) of 47% and median progression-free survival (mPFS) of 20.1 months for Tafinlar + Mekinist compared to 11% ORR and 7.4 months mPFS for standard of care1,2
Approval also... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 19, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Expanded Indication for Telix ’s Illuccix to Include Patient Selection for PSMA-Directed Radioligand Therapy
Indianapolis, IN (United States) | 16 March 2023 -- Telix Pharmaceuticals today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 16, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome
SAN DIEGO–(BUSINESS WIRE)–Mar. 10, 2023– Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 13, 2023 Category: Drugs & Pharmacology Source Type: news
