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RSS FeedPosted by Michael Wonder on 12 Feb 2018
U.S. FDA files new drug application under priority review for migalastat for treatment of Fabry disease
12 February 2018 - Six month PDUFA goal date is 13 August 2018. ...
Posted by Michael Wonder on 11 Feb 2018
Salix provides update on FDA submission for Plenvu
9 February 2018 - Salix Pharmaceuticals and its partner Norgine have received notice that the U.S. FDA has extended the PDUFA ...
Posted by Michael Wonder on 11 Feb 2018
F.D.A. chief goes against the administration stereotype
11 February 2018 - Dr. Scott Gottlieb isn’t rolling back his agency’s mission, although he is straddling the interests of ...
Posted by Michael Wonder on 10 Feb 2018
Grifols HyperRAB (rabies immune globulin [human]) 300 IU/mL receives FDA approval to treat patients exposed to rabies virus infection
6 February 2018 - Reduced volume of medication offers potential for fewer injections for patients. ...
Posted by Michael Wonder on 09 Feb 2018
60 Degrees Pharmaceuticals receives priority review designation for malaria drug
7 February 2018 - 60 Degrees Pharmaceuticals received priority review designation from the US FDA for tafenoquine for prevention of malaria ...
Posted by Michael Wonder on 09 Feb 2018
Zytiga (abiraterone acetate) plus prednisone approved for treatment of earlier form of metastatic prostate cancer
8 February 2018 - Findings from pivotal Phase 3 LATITUDE clinical trial data demonstrated statistically significant and clinically meaningful improvements in ...
Posted by Michael Wonder on 08 Feb 2018
Novartis receives FDA approval for Cosentyx label update to include moderate-to-severe scalp psoriasis
8 February 2018 - This follows a similar European label update in June 2017. ...
Posted by Michael Wonder on 08 Feb 2018
Sage Therapeutics receives FDA breakthrough therapy designation for SAGE-217 for the treatment of major depressive disorder
7 February 2018 - Designation offers potential for expedited development and review, and highlights the urgent need for additional treatment options ...
Posted 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
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. ...