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RSS FeedPosted by Michael Wonder on 03 Nov 2017
GSK’s investigational BCMA antibody-drug conjugate receives breakthrough therapy designation from US FDA for relapsed and refractory multiple myeloma
2 November 2017 - GlaxoSmithKline today announced that it has received breakthrough therapy designation from the U.S. FDA for GSK2857916 monotherapy ...
Posted by Michael Wonder on 02 Nov 2017
FDA grants rare paediatric disease designation to ArQule's miransertib (ARQ 092) for the treatment of Proteus syndrome
1 November 2017 - ArQule today announced that the U.S. FDA has granted rare paediatric disease designation to miransertib (ARQ ...
Posted by Michael Wonder on 02 Nov 2017
FDA grants fast track designation to Visterra’s VIS410 for treatment of hospitalised patients with influenza A
1 November 2017 - Company plans to initiate Phase 2b clinical trial in early 2018. ...
Posted by Michael Wonder on 01 Nov 2017
GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S. Food and Drug Administration for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
30 October 2017 - GW Pharmaceuticals today announced it has completed the rolling submission of a new drug application to ...
Posted by Michael Wonder on 01 Nov 2017
Bayer announces BAY94-9027 biologics license application accepted by U.S. Food & Drug Administration
30 October 2017 - The U.S. FDA has accepted Bayer's biologics license application filing for BAY94-9027, an extended half-life site-specifically PEGylated ...
Posted by Michael Wonder on 01 Nov 2017
Geron announces fast track designation granted to imetelstat for lower risk myelodysplastic syndromes
31 October 2017 - Expanded part 1 of IMerge is open for patient enrolment. ...
Posted by Michael Wonder on 01 Nov 2017
Citius Pharmaceuticals receives fast track designation by FDA For Mino-Lok investigational trial
31 October 2017 - Citius Pharmaceuticals announced today it has received official notice from the U. S. FDA that the investigational ...
Posted by Michael Wonder on 31 Oct 2017
Novartis submits application to FDA for Kymriah (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy
31 October 2017 - Submission based on updated analyses from global, multi-centre Phase II JULIET study, which met primary endpoint, including ...
Posted by Michael Wonder on 31 Oct 2017
FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections
31 October 2017 - Agency completes eight capability assessments as part of the Mutual Recognition Agreement between the U.S. and European ...
Posted by Michael Wonder on 31 Oct 2017
FDA approves new treatment for adults with mantle cell lymphoma
31 October 2017 - The U.S. FDA today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle ...
Posted by Michael Wonder on 30 Oct 2017
A new team aims to slash drug development time — with help from the feds
27 October 2017 - A global pharma company is teaming up with federal research labs and academics in an ambitious ...
Posted by Michael Wonder on 30 Oct 2017
Bayer receives FDA approval for Xarelto 10 mg once daily for the extended treatment of venous thromboembolism
30 October 2017 - Rivaroxaban (Xarelto) 10 mg once daily significantly reduces the risk of recurrent venous thromboembolism compared with aspirin ...
Posted by Michael Wonder on 29 Oct 2017
Atara Biotherapeutics receives rare paediatric disease designation from FDA for ATA230 for treatment of congenital cytomegalovirus infection
26 October 2017 - Atara Biotherapeutics today announced that ATA230 was granted rare paediatric disease designation for the treatment of ...
Posted by Michael Wonder on 29 Oct 2017
Heron Therapeutics granted FDA fast track designation for HTX-011 to reduce post-operative pain and the need for opioid analgesics for 72 hours
26 October 2017 - Phase 3 studies for HTX-011 ongoing; NDA filing planned for 2018. ...
Posted by Michael Wonder on 28 Oct 2017
Achaogen submits plazomicin new drug application to the U.S. FDA for treatment of complicated urinary tract infections and bloodstream infections
26 October 2017 - Investigational drug has potential to treat certain multi-drug resistant gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae. ...