Blog
RSS FeedPosted by Michael Wonder on 08 Feb 2018
Glaxo's key drug gains time as FDA denies Novartis generic
8 February 2018 - Sandoz unit will provide agency with details on Advair copy. ...
Posted by Michael Wonder on 08 Feb 2018
Verastem submits new drug application to U.S. FDA for duvelisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia leukaemia/small lymphocytic lymphoma and follicular lymphoma
7 February 2018 - Verastem today announced it has submitted a new drug application to the U.S. FDA seeking full approval ...
Posted by Michael Wonder on 08 Feb 2018
US FDA approves Gilead’s Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for treatment of HIV-1 infection
7 February 2018 - In clinical trials, Biktarvy demonstrated high efficacy, few interactions with other drugs and a high barrier to ...
Posted by Michael Wonder on 08 Feb 2018
Ensysce Biosciences receives fast track designation for PF614, BIO-MD abuse deterrent extended release oxycodone prodrug
29 January 2018 - Ensysce Biosciences is pleased to announce that the FDA has granted Fast Track designation for the development ...
Posted by Michael Wonder on 08 Feb 2018
GSK’s meningitis B vaccine Bexsero receives breakthrough therapy designation from US FDA for prevention of invasive meningococcal disease in children 2-10 years of age
7 February 2018 - GlaxoSmithKline today announced that it has received breakthrough therapy designation from the U.S. FDA for its meningitis ...
Posted by Michael Wonder on 08 Feb 2018
Rejuvenating regenerative medicine regulation
7 February 2018 - The FDA recently made long-awaited progress toward protecting patients from interventions involving human cell- and tissue-based products ...
Posted by Michael Wonder on 07 Feb 2018
SIGA Technologies announces FDA accepts NDA and grants priority review for oral Tpoxx to treat smallpox
7 February 2018 - If approved, Tpoxx would be the first treatment for smallpox. ...
Posted by Michael Wonder on 06 Feb 2018
Zogenix announces receipt of FDA breakthrough therapy designation for ZX008 in Dravet syndrome
6 February 2018 - Designation based on positive results from Study 1, the first pivotal Phase 3 trial of ZX008. ...
Posted by Michael Wonder on 06 Feb 2018
Paratek completes submission of new drug applications to U.S. FDA for oral and intravenous omadacycline for pneumonia and skin infections
5 February 2018 - Paratek Pharmaceuticals announced today that on February 2, 2018, it completed the submission of two new drug ...
Posted by Michael Wonder on 05 Feb 2018
Ferring's Zomacton (somatropin) for injection receives FDA approval to treat growth hormone deficiency in adults
31 January 2018 - Ferring expands U.S. endocrinology portfolio. ...
Posted by Michael Wonder on 05 Feb 2018
Capricor receives FDA regenerative medicine advanced therapy designation for Duchenne muscular dystrophy therapy
5 February 2018 - CAP-1002 to benefit from expedited review program for drugs for unmet needs. ...
Posted by Michael Wonder on 05 Feb 2018
AMAG Pharmaceuticals announces FDA approval of supplemental new drug application for Feraheme (ferumoxytol injection)
5 February 2018 - Feraheme is now a treatment option for all eligible adult patients with iron deficiency anaemia. ...
Posted by Michael Wonder on 04 Feb 2018
The Health 202: How 'Right to Try' caught Washington's eye
1 February 2018 - Of 7,267 bills proposed by members of Congress over the past year, President Trump mentioned just ...
Posted by Michael Wonder on 04 Feb 2018
Alnylam announces FDA acceptance of new drug application and priority review status for patisiran, an investigational RNAi therapeutic for the treatment of hereditary ATTR amyloidosis
1 February 2018 - PDUFA date set for 11 August 2018. ...
Posted by Michael Wonder on 02 Feb 2018
Protalix BioTherapeutics’ pegunigalsidase alfa receives fast track designation from the U.S. FDA
31 January 2018 - Fast Track designation highlights high unmet medical need in the treatment of Fabry disease. ...