Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of ...
Tags: Genzyme, Biologics License Application, Lemtrada, multiple sclerosis
GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA dry powder ...
Tags: Asthma Treatment, Medicine
GlaxoSmithKline (GSK) and Danish biotechnology firm Genmab have filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the use of its leukaemia drug Arzerra (ofatumumab) in combination ...
Tags: GlaxoSmithKline, CLL Patients
Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has accepted and filed the company's supplemental biologics license application (sBLA) for subcutaneous use of Xolair (omalizumab) in ...
The US FDA has cleared Sanofi Pasteur's supplemental biologics license application (sBLA) licensing four-strain influenza vaccine, Fluzone Quadrivalent, for broad age range of children and adults. As the first and only four-strain ...
Tags: Influenza Vaccine, Medicine
The US FDA has accepted Genzyme Lemtrada (alemtuzumab) biologics license application (sBLA) for review for relapsing multiple sclerosis (RMS). Genzyme also reported encouraging early US launch indicators for Aubagio (teriflunomide) such ...
Tags: FDA, biologics license application, relapsing multiple sclerosis
Janssen Biotech and Janssen Biologics are seeking approval for Stelara in the US and Europe for the treatment of active psoriatic arthritis. A supplemental biologics license application (sBLA) was submitted to the FDA and a Type II ...
Genzyme, a Sanofi company, has submitted a supplemental biologics license application (sBLA) to the FDA and marketing authorization application (MAA) to EMA for Lemtrada to treat relapsing multiple sclerosis (RMS). In collaboration with ...
Tags: sBLA, relapsing multiple sclerosis, RMS
Janssen Biotech and Janssen Biologics have submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of Simponi ...
Tags: Simponi, golimumab, active ulcerative colitis, anti-tumor necrosis factor
Genzyme, a Sanofi company, has received a refuse to file letter from the US Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment ...
Tags: Genzyme, Lemtrada marketing, FDA
Emergent BioSolutions has received FDA approval for its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax to a three-dose primary series of intramuscular injections at zero, one, and six ...
Tags: Medicine, Emergent BioSolutions, Anthrax Vaccine Adsorbed