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RSS FeedPosted by Michael Wonder on 13 Mar 2018
AmnioFix injectable granted regenerative medicine advanced therapy designation by the FDA for the treatment of osteoarthritis of the knee
9 March 2018 - MiMedx Group today announced that the U.S. FDA has granted MiMedx's micronized amniotic tissue, AmnioFix Injectable, ...
Posted by Michael Wonder on 24 Feb 2018
FDA accepts Shire’s biologics license application and grants priority review for lanadelumab for the prevention of attacks in hereditary angioedema patients
23 February 2018 - Lanadelumab, the first long-acting investigational monoclonal antibody in hereditary angioedema, is being evaluated for the prevention of ...
Posted by Michael Wonder on 16 Feb 2018
FDA grants priority review for Genentech’s Rituxan (rituximab) for pemphigus vulgaris
13 February 2018 - The FDA previously granted breakthrough therapy designation and orphan drug designation for Rituxan in pemphigus vulgaris. ...
Posted by Michael Wonder on 15 Feb 2018
FDA accepts new drug application and grants priority review for ivosidenib in relapsed or refractory AML with an IDH1 mutation
15 February 2018 - PDUFA date set for 21 August 2018 ...
Posted 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 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 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 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 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 30 Jan 2018
FDA has to explain why Amgen was denied a key marketing incentive
30 January 2018 - Did the FDA treat Amgen differently than Johnson & Johnson when reviewing applications for their drugs? ...
Posted by Michael Wonder on 30 Jan 2018
Abeona receives FDA regenerative medicine advanced therapy designation for EB-101 gene therapy in epidermolysis bullosa
29 January 2018 - First gene therapy RMAT designation for epidermolysis bullosa. ...
Posted by Michael Wonder on 20 Jan 2018
U.S. FDA grants priority review for daratumumab in front line multiple myeloma
19 January 2018 - 21 May 2018 PDUFA date. ...
Posted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 08 Jan 2018
Ionis' inotersen NDA accepted for priority review by the FDA
8 January 2018 - Ionis Pharmaceuticals announced today that its new drug application for inotersen has been accepted for priority review ...
Posted by Michael Wonder on 02 Jan 2018
Achaogen announces FDA acceptance of new drug application with priority review for plazomicin for treatment of complicated urinary tract infections and bloodstream infections
2 January 2018 - FDA sets action date of 25 June 2018. ...