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Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen’s EU-licensed Neulasta®* (pegfilgrastim) – a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product.
KemPharm, Inc. announced that the New Drug Application (NDA) for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA). In addition, the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.
Aurobindo Pharma Limited announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 500 mg/100 mL (5 mg/mL), and 750 mg/150 mL (5 mg/mL), single-use containers. The product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin® (Levaquin in 5 % Dextrose) by Janssen Pharmaceuticals, Inc.
Do you experience frequent mood swings? Scientists have found a group of drugs that could help treat mood disorders and also relieve chronic pain.
After the age of nine months, the development of the infant gut microbiota is driven by diet, not maternal obesity, a new study says.The gut microbiota is a complex community of microorganisms that live in the digestive tract.
The Health Ministry on Thursday launched the National Framework for Malaria Elimination with a view to eradicating the mosquito-borne disease from India by 2030.
Feeding fish oil-based diet for three weeks has been found to slow progression of Alzheimer's like symptoms in mouse models of the disease, reports a new study, supporting viability of a dietary approach to combat the brain disorder in humans.
Researchers have found that a US Food and Drug Administration (FDA)-approved drug currently used for obese patients and Type-2 diabetics has the potential to be used in the treatment of cocaine dependence.
Alcohol allows gut bacteria to migrate to the liver, promoting alcohol-induced liver diseases, reveals a new study.
British researchers have identified a key protein that can control how breast cancer cells spread in the body.The study sheds light on how cancer cells leave the blood vessels to travel to a new part of the body, said the researchers from University of Manchester in Britain.