Apellis Announces U.S. FDA Approval of the Empaveli Injector, a Device to Streamline Self-Administration
WALTHAM, Mass., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved the Empaveli® Injector. The Empaveli Injector is a compact, single-use,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 2, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Technegas (Technetium Tc 99-m Labeled Carbon) Radioactive Diagnostic Agent
October 2, 2023 -- Cyclopharm Limited (ASX: CYC) announces the company has received United States Food and Drug Administration (USFDA) approval to commence commercial sales of Technegas in the US market. The approval opens for Cyclopharm the single... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 2, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Rivfloza (nedosiran) for the Treatment of Primary Hyperoxaluria Type 1 (PH1)
PLAINSBORO, N.J., Oct. 2, 2023 /PRNewswire/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved Rivfloza (nedosiran) injection 80 mg, 128 mg, or 160 mg, a once-monthly subcutaneous ribonucleic acid... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 2, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Tofidence (tocilizumab-bavi), a Biosimilar to Actemra
CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 29, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Exxua (gepirone) for the Treatment of Major Depressive Disorder in Adults
HOUSTON, Sept. 28, 2023 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company committed to developing novel therapies to address unmet needs in psychiatry and neurology, is pleased to announce that the U.S.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for the Treatment of Late-Onset Pompe Disease
PHILADELPHIA, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Subcutaneous Administration of Takeda's Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis
OSAKA, Japan and CAMBRIDGE, Massachusetts, September 27, 2023– Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) administration of Entyvio® (vedolizumab) for maintenance therapy in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 27, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Bosutinib for Pediatric Patients with Chronic Myelogenous Leukemia
September 27, 2023 -- On September 26, 2023, the Food and Drug Administration approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 27, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Ryzumvi (phentolamine) Ophthalmic Solution for the Treatment of Pharmacologically-Induced Mydriasis
FARMINGTON HILLS, Mich., and PITTSBURGH, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 27, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Likmez (metronidazole) Oral Suspension for the Treatment of Parasitic and Anaerobic Bacterial Infections
HALIFAX, Nova Scotia--(BUSINESS WIRE) September 25, 2023 -- Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the“Company” or“Appili”), a biopharmaceutical company focused on drug development for infectious diseases and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 25, 2023 Category: Drugs & Pharmacology Source Type: news
US FDA Approves Jardiance for the Treatment of Adults with Chronic Kidney Disease
RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 22, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular filtration rate... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 22, 2023 Category: Drugs & Pharmacology Source Type: news
RedHill Announces FDA sNDA Approval for Simplified Dosage Regimen for Talicia
FDA approves supplemental new drug application (sNDA) for Talicia, changing dosing to a simplified three times daily (TID) regimen, which may support increased patient adherence and treatment outcomes
Talicia is the leading branded first-line... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Ojjaara (momelotinib) for Myelofibrosis Patients with Anemia
Approval is for use in myelofibrosis patients with anemia regardless of prior myelofibrosis therapy
Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease, and over 30% will discontinue treatment due to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 15, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves New and Updated Indications for Temozolomide Under Project Renewal
On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Aphexda (motixafortide) to Mobilize Hematopoietic Stem Cells for Autologous Transplantation in Patients with Multiple Myeloma
Aphexda is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade
One dosage of Aphexda plus filgrastim enabled a majority of patients to achieve the collection goal of≥ 6 million... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 11, 2023 Category: Drugs & Pharmacology Source Type: news
