SAN DIEGO--(BUSINESS WIRE)-- Apricus Biosciences (“Apricus Bio”) (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT ® drug delivery technology ...
Gary Lyman, MD, MPH, an oncologist and hematologist, compares the uptake of filgrastim biosimlars with pegfilgrastim biosimilars. Gary Lyman, MD, MPH, is an oncologist, hematologist, and public health ...
PURPOSE: This multicenter, randomized, double-blind, active-control study was designed to determine whether a single subcutaneous injection of pegfilgrastim (SD/01, sustained-duration filgrastim; 100 ...
On January 7, 2015, Sandoz, the generics wing of Novartis, announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended its biosimilar filgrastim (EP2006) for approval in the ...
The first biosimilar product in the United States has been approved by the US Food and Drug Administration, in a move described by the agency's director, Janet Woodcock, as a "significant milestone." ...
The FDA has approved the CXCR4 antagonist motixafortide (Aphexda) for use with filgrastim (Neupogen) to mobilize stem cells for autologous transplantation in multiple myeloma, BioLineRx announced on ...
Novartis ($NVS) will be the first to hit U.S. shores with a copy of a blockbuster biotech drug, winning FDA approval for its take on Amgen's ($AMGN) Neupogen and ...
Sandoz announced today that Sandoz Japan has received marketing authorization approval for its biosimilar filgrastim (Kyowa Hakko Kirin's GRAN®). The product, which will be marketed as Filgrastim BS ...
The US Food and Drug Administration (FDA) has expanded the indication for tbo-filgrastim (Granix, Teva), now allowing it to be self-administered by patients and their caregivers. Tbo-filgrastim, a ...
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