CMP Pharma, Inc Announces that Liqrev, the First and Only Ready-made FDA-approved Liquid Suspension of Sildenafil is Now Available
FARMVILLE, N.C., June 21, 2023/— CMP Pharma, Inc. announced today that Liqrev (Sildenafil) Oral Suspension, 10 mg/mL, the first and only FDA-approved ready-made oral liquid of sildenafil, is now available.
Liqrev is a liquid oral suspension... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Lodoco (colchicine) as the First Anti-Inflammatory Drug for Cardiovascular Disease
Parsippany, NJ– June 20, 2023– AGEPHA Pharma USA, LLC, today announced that, following a Priority Review, the U.S. Food and Drug Administration (FDA) has approved Lodoco® as the first anti-inflammatory atheroprotective... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for Subcutaneous Use in Generalized Myasthenia Gravis
SAN DIEGO, June 20, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ( " Halozyme " ) today announced that argenx received U.S. Food and Drug Administration (FDA) approval for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 20, 2023 Category: Drugs & Pharmacology Source Type: news
Pfizer ’s Talzenna (talazoparib) in Combination with Xtandi (enzalutamide) Receives U.S. FDA Approval for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
NEW YORK--(BUSINESS WIRE) June 20, 2023 -- Pfizer (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
June 20, 2023 -- Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Columvi (glofitamab-gxbm) Bispecific Antibody for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
South San Francisco, CA -- June 15, 2023 -- 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 Columvi (glofitamab-gxbm) for the treatment of adult... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 15, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Bylvay for Patients Living with Cholestatic Pruritus Due to Alagille Syndrome
PARIS, FRANCE, 13 June 2023– Ipsen (Euronext: IPN: ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has approved Bylvay® (odevixibat) for the treatment of cholestatic pruritus in patients from 12 months of age... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 13, 2023 Category: Drugs & Pharmacology Source Type: news
Ironwood Pharmaceuticals Announces FDA Approval of New Indication for Linzess (linaclotide) for the Treatment of Functional Constipation in Pediatric Patients Ages 6-17 Years-Old
BOSTON--(BUSINESS WIRE) June 12, 2023 -- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Linzess® (linaclotide) as a once-daily... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 12, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Vevye (cyclosporine) Ophthalmic Solution for the Treatment of the Signs and Symptoms of Dry Eye Disease
Heidelberg, Germany and Cambridge, MA, USA, June 8, 2023– Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 8, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves New Indication for Merck ’s Prevymis (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients
RAHWAY, N.J.--(BUSINESS WIRE) June 6, 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 a new indication for Prevymis® (letermovir) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 6, 2023 Category: Drugs & Pharmacology Source Type: news
Injectafer Approved in the U.S. for the Treatment of Iron Deficiency in Adult Patients with Heart Failure
BASKING RIDGE, N.J.& SHIRLEY, N.Y.--(BUSINESS WIRE) June 05, 2023 --Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) approved Injectafer®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 5, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Lynparza (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Lynparza combination showed a clinically meaningful reduction in risk of disease progression or death in these patients in the Phase 3 PROpel trial
First approval of a PARP inhibitor in combination with a new hormonal agent in mCRPC
RAHWAY,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 1, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Abrysvo (respiratory syncytial virus vaccine) for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults
NEW YORK--(BUSINESS WIRE) May 31, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Abrysvo™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 31, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Posluma (flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer
MONROE TOWNSHIP, N.J.& OXFORD, England--(BUSINESS WIRE) May 30, 2023 --Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 30, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Inpefa (sotagliflozin) for the Treatment of Heart Failure
THE WOODLANDS, Texas, May 26, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Inpefa™ (sotagliflozin), a once-daily oral tablet to reduce the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 27, 2023 Category: Drugs & Pharmacology Source Type: news
