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RSS FeedPosted by Michael Wonder on 26 Apr 2018
Mission possible: moving the needle forward to advance health equity
26 April 2018 - Every April our country observes National Minority Health Month to spotlight what we’re doing to eliminate health ...
Posted by Michael Wonder on 26 Apr 2018
FDA grants fast track designation for OrphoMed’s ORP-101 for treatment of IBS-D
25 April 2018 - OrphoMed announced today that the U.S. FDA has granted fast track designation for the Company’s lead ...
Posted by Michael Wonder on 26 Apr 2018
Synlogic receives fast track designation for SYNB1618, a synthetic biotic medicine for the treatment of phenylketonuria
25 April 2018 - Phase 1/2a clinical study of SYNB1618 evaluating safety and tolerability as well as exploratory endpoints expected ...
Posted by Michael Wonder on 26 Apr 2018
Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada
26 April 2018 - The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into ...
Posted by Michael Wonder on 26 Apr 2018
Enzychem Lifesciences' fast track designation for chemo-radiation induced oral mucositis had been granted by the FDA
24 April 2018 - On 14 March, the U.S. FDA has granted Enzychem Lifesciences fast track designation of clinical study of ...
Posted by Michael Wonder on 26 Apr 2018
Astellas submits new drug applications for approval of gilteritinib for the treatment of FLT3 mutation positive relapsed or refractory acute myeloid leukaemia
24 April 2018 - Astellas Pharma today announced that it submitted on March 23, 2018, a new drug application (NDA) for ...
Posted by Michael Wonder on 25 Apr 2018
Efficacy, safety, and regulatory approval of FDA–designated breakthrough and non-breakthrough cancer medicines
24 April 2018 - The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. ...
Posted 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 ...