The Dana-Farber Cancer Institute issued the following news release:. A targeted drug whose clinical testing was led by Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, has become a standard first-line therapy for certain newly diagnosed patients with advanced kidney cancer. The drug, cabozantinib, was approved today by the U.S. Food and Drug.
IRVINE, Calif.- Aerie Pharmaceuticals, Inc., an ophthalmic pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma and other diseases of the eye, today announced that the U.S. Food and Drug Administration has approved Rhopressa 0.02% for t
Aeterna Zentaris Inc., a specialty biopharmaceutical company engaged in developing and commercializing pharmaceutical therapies, announced today that the U.S. Food and Drug Administration has granted marketing approval for Macrilen?, an orally available ghrelin agonist, to be used in the diagnosis of patients with adult growth hormone deficienc
Amphastars newly approved product was determined by the FDA to be therapeutically equivalent to Nitropress sold in the United States by Valeant Pharmaceuticals. According to IQVIA, U.S. brand and generic sales of Sodium Nitroprusside Injection, 25 mg/mL, 2 mL vials were approximately $73.8 million for the 12 months ended September 30, 2017.
Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration has approved Opdivo injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. 1 The purpose of adjuvant therapy is to reduce the risk of recurre
The University of Pennsylvania's Perelman School of Medicine issued the following news release:. In a historic move, the U.S. Food and Drug Administration today approved a gene therapy initially developed by researchers at the University of Pennsylvania and Children's Hospital of Philadelphia for the treatment of a rare, inherited form of retinal..
Genentech, a member of the Roche Group, today announced the U.S. Food and Drug Administration has approved Perjeta , in combination with Herceptin and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. The FDA has also converted the previously granted accelerated approval of the Perjeta-based
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene. "We're at a turning point when it comes to this novel form of therapy and at the FDA, we're f
-Spark Therapeutics, a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, announced today that the U.S. Food and Drug Administration has approved LUXTURNA, a one-time gene therapy product indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
The treatment, developed by the Philadelphia drugmaker Spark Therapeutics and researchers at Children's Hospital of Philadelphia and the University of Pennsylvania, represents the first U.S. therapy for a disease caused by mutations in a specific gene. Spark Therapeutics' stock traded lower after the announcement, likely because of uncertainty abou
WASHINGTON- U.S. health officials on Tuesday approved the nation's first gene therapy for an inherited disease, a treatment that improves the sight of patients with a rare form of blindness. The approval for Spark Therapeutics offers a life-changing intervention for a small group of patients with a vision-destroying genetic mutation and hope for ma
New York, NY 12/20/2017 Top line results may soon be in at CEL-SCI, which concluded patient enrollment and dosing in the world's largest Phase III trial in the treatment of head and neck cancer. According to the study's protocol, the effectiveness of CEL-SCI's drug in prolonging life can only be judged after 298 of the enrolled patients have
New Delhi, Dec 20: The United States Food and Drug Administration has cleared Montelukast Sodium, a bulk drug/ API manufactured by Morepen Laboratories Ltd., for sale in the US market. This gives Morepen an entry into the Rs. 2000 crore US market for Montelukast. Expressing happiness on the development, Sushil Suri, Chairman and Managing Director,
Morepen Laboratories has received approval from United States Food and Drug Administration for Montelukast Sodium, a bulk drug/ API to sell in the US market. This gives Morepen an entry into the Rs2, 000 cr US market for Montelukast. Morepen Laboratories Ltd is currently trading at Rs29.25, up by Rs4 or 15.84% from its previous closing of Rs25.25 o
PENTAX Medical, an industry leader in endoscopic imaging, announced the U.S. launch of its new C.A.P. HD Duodenoscope, the first FDA- cleared duodenoscope with a disposable distal cap. "We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices," said William Mais
Pfizer, a pharmaceutical company, issued the following news release:. Pfizer Inc. today announced the U.S. Food and Drug Administration approved a supplemental New Drug Application to expand the indication for BOSULIF (R) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia.
Amphastar Pharmaceuticals, Inc., announced that today the U.S. Food and Drug Administration granted approval of its abbreviated new drug application for Sodium Nitroprusside Injection 25 mg/mL, 2 mL single dose vial, indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crisis. Amphastar s newl
Several years ago, I started writing this informational column of which I am very proud of, possibly because it has been the first where the topic of stem cells and the fascinating new branch of medicine called "Regenerative Medicine" are thoroughly discussed. However, the public at large knows very little about the wide array of Human Cell related
Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announces that the U.S. Food and Drug Administration today approved a supplemental New Drug Application for Pfizer's BOSULIF . The approved sNDA expands the indication for BOSULIF
Exelixis, Inc. today announced that the U.S. Food and Drug Administration approved CABOMETYX tablets for the expanded indication of patients with advanced renal cell carcinoma. Today s label expansion follows the initial FDA approval of CABOMETYX in April 2016 for the treatment of patients with advanced RCC who have previously received...
WASHINGTON- In a historic move, the Food and Drug Administration on Tuesday approved a pioneering gene therapy for a rare form of childhood blindness, the first such treatment cleared in the United States for an inherited disease. The approval signals a new era for the gene therapy field, which struggled for decades to overcome devastating setbacks
SILVER SPRING, Md., Dec. 19, 2017/ PRNewswire-USNewswire/ The U.S. Food and Drug Administration today approved Luxturna, a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease c
Pfizer has revealed that the FDA has passed marketing approval for Xeljanz for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs. Xeljanz was originally approved by the FDA in 2012. The decision makes Xeljanz the first avail