Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2018
AbbVie submits biologics license application to U.S. FDA for investigational treatment risankizumab for moderate to severe plaque psoriasis
25 April 2018 - The biologics license application is supported by four Phase 3 studies of more than 2,000 patients with ...
Posted by Michael Wonder on 25 Apr 2018
Once daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD
24 April 2018 - GlaxoSmithKline Innoviva today announced that the US FDA has approved an expanded indication for Trelegy Ellipta (fluticasone ...
Posted by Michael Wonder on 25 Apr 2018
Otsuka’s Jynarque (tolvaptan) approved by U.S. FDA as the first treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
25 April 2018 - Data from two phase 3 clinical trials showed that Jynarque (tolvaptan) slowed kidney function decline in adults ...
Posted by Michael Wonder on 24 Apr 2018
FDA accepts Veloxis's supplemental new drug application for the de novo indication for Envarsus XR
19 April 2018 - Veloxis Pharmaceuticals announced today that the U.S. FDA has accepted for standard review the Company's supplemental ...
Posted by Michael Wonder on 24 Apr 2018
FDA Advisory Committee recommends the approval of baricitinib 2 mg, but not 4 mg, for the treatment of moderately-to-severely active rheumatoid arthritis
23 April 2018 - Eli Lilly and Incyte Corporation announced today that the U.S. FDA Arthritis Advisory Committee recommended approval of ...
Posted by Michael Wonder on 23 Apr 2018
Abeona announces FDA grants RMAT designation to ABO-102 gene therapy in MPS IIIA
23 April 2018 - First gene therapy using AAV approach granted regenerative medicine advanced therapy designation. ...
Posted by Michael Wonder on 23 Apr 2018
Sage Therapeutics submits new drug application to U.S. FDA for intravenous brexanolone in the treatment of post-partum depression
23 April 2018 - Brexanolone IV submission is the company’s first new drug application. ...
Posted by Michael Wonder on 23 Apr 2018
MeiraGTx announces AAV-RPGR granted fast track designation by U.S. FDA for treatment of X-linked retinitis pigmentosa due to RPGR deficiency
23 April 2018 - MeiraGTx Limited today announced that the U.S. FDA has granted fast track designation for AAV-RPGR for the ...
Posted by Michael Wonder on 23 Apr 2018
Synthetic Biologics provides update on development of SYN-004 (ribaxamase), for the prevention of C. difficile infection
23 April 2018 - Synthetic Biologics today announced that it has preliminary agreement from the U.S. FDA on a proposed ...
Posted by Michael Wonder on 23 Apr 2018
Pfizer provides update on proposed trastuzumab biosimilar
23 April 2018 - Pfizer today announced that it received a complete response letter from the United States FDA in response ...
Posted by Michael Wonder on 23 Apr 2018
Pfizer granted FDA breakthrough therapy designation for Trumenba (meningococcal Group B vaccine) for the prevention of invasive meningococcal B disease in children aged 1 to 9 years
23 April 2018 - Pfizer today announced that Trumenba (meningococcal Group B vaccine) received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 21 Apr 2018
U.S. FDA grants fast track designation for Polyphor's innovative immuno-oncology candidate balixafortide in combination with eribulin as third-line therapy for metastatic breast cancer
19 April 2018 - Polyphor announced today that the U.S. FDA has granted fast track designation for its novel immuno-oncology candidate ...
Posted by Michael Wonder on 21 Apr 2018
Helsinn Group announces the FDA approval of the IV formulation of Akynzeo (fosnetupitant/palonosetron) in the United States
20 April 2018 - Helsinn today announces that the U.S. FDA has approved the intravenous formulation of Akynzeo (NEPA, a ...
Posted by Michael Wonder on 21 Apr 2018
FDA commissioner to drug middlemen: you're part of the problem
19 April 2018 - The FDA has approved nine biosimilars, generic versions of biologic medicines, but only three are available in ...
Posted by Michael Wonder on 19 Apr 2018
FDA staff raises safety concerns over Lilly/Incyte arthritis drug
19 April 2018 - An experimental rheumatoid arthritis drug developed by Eli Lilly and Incyte poses serious risks of deadly blood ...