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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Biosimilars guidances
The US FDA has issued a series of guidance documents on the registration/regulation of biosimilar medicines. ...
Posted by Michael Wonder on 05 Aug 2015
Boehringer Ingelheim submits applications for approval of idarucizumab, specific reversal agent to dabigatran etexilate (Pradaxa), to EMA, FDA and Health Canada
Boehringer Ingelheim today announces that idarucizumab has been submitted for approval of marketing authorisation to the European Medicines Agency (EMA), ...
Posted by Michael Wonder on 05 Aug 2015
Shire submits application to the U.S. FDA for approval of lifitegrast for treatment of dry eye disease in adults
Shire plc. announced today that the company has submitted a New Drug Application (NDA) with the U. S. Food and Drug ...
Posted by Michael Wonder on 05 Aug 2015
Jazz Pharmaceuticals receives FDA approval for intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi)
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved the intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi). Erwinaze is indicated ...
Posted by Michael Wonder on 05 Aug 2015
Spectrum Pharmaceuticals files a new drug application with the FDA for captisol-enabled (propylene glycol-free) melphalan
Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and ...
Posted by Michael Wonder on 05 Aug 2015
AcelRx Pharmaceuticals receives complete response letter from FDA for NDA for Zalviso
AcelRx Pharmaceuticals, Inc, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of ...
Posted by Michael Wonder on 05 Aug 2015
New INN publication: “Biological Qualifier An INN Proposal”
The “Biological Qualifier An INN Proposal” document has been published on the INN website. ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts supplemental biologics license application (sBLA) for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy in advanced non small-cell lung cancer and grants priority review
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 05 Aug 2015
Actelion submits US FDA new drug application for selexipag (Uptravi) in patients with pulmonary arterial hypertension
Actelion Ltd today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Orbactiv to treat skin infections
The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections. ...
Posted by Michael Wonder on 05 Aug 2015
Basilea gets FDA request for more data on pneumonia drug
Basilea Pharmaceutica AG, a Swiss developer of an antibiotic to treat pneumonia, said the U.S. Food and Drug Administration asked for more ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants fast track designation to Genzyme's investigational substrate reduction therapy for the treatment of Fabry disease
Sanofi and its subsidiary Genzyme announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer receives US FDA breakthrough therapy designation for Xalkori (crizotinib) for the treatment of patients with ROS1 positive non small-cell lung cancer
Pfizer Inc. announced today that Xalkori (crizotinib) received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Gazyva (obinutuzumab) supplemental biologics license application with new data in previously untreated chronic lymphocytic leukaemia
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer and Protalix BioTherapeutics announce FDA approval of pediatric indication for Elelyso (taliglucerase alfa) for injection, for intravenous use for the treatment of Type 1 Gaucher disease
Pfizer Inc. and Protalix BioTherapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Elelyso (taliglucerase alfa) for injection for ...