The U.S. Food and Drug Administration has approved the first biosimilar to pegfilgrastim (Neulasta, Amgen), a granulocyte colony-stimulating factor used to reduce infection risk in patients with ...
The drug decreases the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. Nilesh Gupta, MD, Lupin, ...
Lupin has received approval from Health Canada for pegfilgrastim, a biosimilar to Amgen's Neulasta. This product will be marketed under the brand name Armlupeg and manufactured at Lupin’s Biotech ...
Holzkirchen, 08 December 2017- Sandoz, a division of Novartis and the global leader in biosimilars, today announced data demonstrating the pharmacokinetics (PK), pharmacodynamics (PD), safety and ...
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Kashiv Biosciences, LLC (“Kashiv” or the “Company”) is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has approved its Biologics License ...
REDWOOD CITY, Calif., Dec. 26, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (CHRS), a commercial-stage biopharmaceutical company focused on the research, development and commercialization of ...
The FINANCIAL — Sandoz, a Novartis company and one of the global leaders in biosimilars, announced on November 18 that the US Food and Drug Administration (FDA) has accepted its Biologics License ...
REDWOOD CITY, Calif., Sept. 25, 2018 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: CHRS), today announced the European Commission (EC) has granted marketing authorization to UDENYCA™ ...
ZURICH, Nov 18 (Reuters) - The U.S. Food and Drug Administration has accepted Novartis unit Sandoz's submission for approval of a biosimilar version of U.S.-based Amgen's Neulasta drug that fights ...
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