FDA Approves Opill (norgestrel) OTC Daily Oral Contraceptive
DUBLIN, July 13, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, announced today that the U.S. Food and Drug Administration (FDA) approved Opill®, a progestin-only daily oral... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 13, 2023 Category: Drugs & Pharmacology Source Type: news
US FDA Approves Expanded Indication for Leqvio (inclisiran) to Include Treatment of Adults with High LDL-C and Who Are At Increased Risk of Heart Disease
Expanded indication now enables broader use of Leqvio for LDL-C reduction in patients with primary hyperlipidemia (high LDL-C) 1
Leqvio can now be used earlier in LDL-C treatment as an adjunct to diet and statin therapy for patients who have not... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 10, 2023 Category: Drugs & Pharmacology Source Type: news
US FDA Approves Expanded Indication for Novartis Leqvio (inclisiran) to Include Treatment of Adults with High LDL-C and Who Are At Increased Risk of Heart Disease
Expanded indication now enables broader use of Leqvio for LDL-C reduction in patients with primary hyperlipidemia (high LDL-C) 1
Leqvio can now be used earlier in LDL-C treatment as an adjunct to diet and statin therapy for patients who have not... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 10, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Medicines360 ’s Supplemental New Drug Application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg as Treatment of Heavy Menstrual Bleeding
SAN FRANCISCO, CA -- July 10, 2023 -- Medicines360, a global nonprofit organization with a mission to catalyze equitable access to quality medicines for women, announced today that the U.S. Food and Drug Administration (FDA) has approved its... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 10, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Grants Traditional Approval for Leqembi (lecanemab-irmb) for the Treatment of Alzheimer ’s Disease
TOKYO and CAMBRIDGE, Mass., July 06, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito,“Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 7, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Roctavian (valoctocogene roxaparvovec-rvox) Gene Therapy for Adults with Severe Hemophilia A
SAN RAFAEL, Calif., June 29, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that the United States Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 29, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Lantidra (donislecel-jujn) Cellular Therapy to Treat Patients with Type 1 Diabetes
June 28, 2023 -- Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 28, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Lantidra Cellular Therapy to Treat Patients with Type 1 Diabetes
June 28, 2023 -- Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 28, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Ngenla (somatrogon-ghla) Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency
NEW YORK& MIAMI--(BUSINESS WIRE) June 28, 2023 -- Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved Ngenla (somatrogon-ghla), a once-weekly, human growth... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 28, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Rystiggo (rozanolixizumab-noli) for the Treatment of Adults with Generalized Myasthenia Gravis
Brussels (Belgium) June 27 2023– UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced Rystiggo® (rozanolixizumab-noli)* has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 27, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Litfulo (ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata
NEW YORK--(BUSINESS WIRE) June 23, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Litfulo™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 23, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Elevidys (delandistrogene moxeparvovec-rokl) Gene Therapy to Treat Duchenne Muscular Dystrophy
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 22, 2023-- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today announced U.S. Food and Drug Administration (FDA) accelerated approval of Elevidys... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 22, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) Colonoscopy Preparation that Tastes Similar to a Sports Drink
BRAINTREE, Mass., June 22, 2023 /PRNewswire/ -- Sebela Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) granted approval of Suflave™ (polyethylene glycol, sodium sulfate, potassium chloride, magnesium... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 22, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Jardiance (empagliflozin) for the Treatment of Type 2 Diabetes in Children 10 Years and Older
RIDGEFIELD, Conn. and INDIANAPOLIS, June 21, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
Conversion From Accelerated to Full Approval
Reinforces Blincyto as Standard of Care for Patients With Minimal Residual Disease at Baseline After Remission
THOUSAND OAKS, Calif., June 21, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2023 Category: Drugs & Pharmacology Source Type: news
