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RSS FeedPosted by Michael Wonder on 14 Sep 2017
Teva receives FDA priority review for first line use of Trisenox (arsenic trioxide) in patients with low to intermediate risk acute promyelocytic leukaemia
12 September 2017 - Teva Pharmaceutical Industries announced today the U.S. FDA has accepted for review the company’s supplemental new ...
Posted by Michael Wonder on 07 Sep 2017
Novimmune receives rare paediatric disease designation from the FDA for its lead drug emapalumab
5 September 2017 - Providing eligibility is confirmed at the time of approval of emapalumab for the treatment of primary haemophagocytic ...
Posted by Michael Wonder on 07 Sep 2017
Enzyvant receives FDA rare paediatric disease designation for investigational therapy RVT-802
5 September 2017 - RVT-802 has also received breakthrough therapy designation, regenerative medicine advanced therapy designation, and orphan drug designation from ...
Posted by Michael Wonder on 30 Aug 2017
FDA accepts BioMarin's pegvaliase biologics license application and grants priority review designation
29 August 2017 - BioMarin Pharmaceutical today announced that the U.S. FDA has accepted for priority review the biologics license application ...
Posted by Michael Wonder on 30 Aug 2017
Prometic receives rare paediatric disease designation from U.S. FDA for its plasminogen replacement therapy
29 August 2017 - Triple designation of orphan drug, fast track status, combined with rare paediatric designation, underscores significant unmet need ...
Posted by Michael Wonder on 29 Aug 2017
La Jolla Pharmaceutical Company announces U.S. FDA acceptance of new drug application for LJPC-501
28 August 2017 - Priority review granted. ...
Posted by Michael Wonder on 28 Aug 2017
FDA grants priority review for Genentech’s Gazyva in previously untreated follicular lymphoma
27 August 2017 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 24 Aug 2017
FDA grants priority review to Genentech's emicizumab for haemophilia A with inhibitors
23 August 2017 - Application based on positive results of Phase III study in adults and adolescents with haemophilia A with ...
Posted by Michael Wonder on 12 Aug 2017
Gilead announces US FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV
10 August 2017 - Final FDA Decision Anticipated by 12 February 2018. ...
Posted by Michael Wonder on 09 Aug 2017
FDA grants priority review and breakthrough therapy designation for Zelboraf (vemurafenib) in Erdheim-Chester disease with BRAF V600 mutation
7 August 2017 - There are currently no FDA-approved treatments for Erdheim-Chester disease, a rare blood disease. ...
Posted by Michael Wonder on 07 Aug 2017
Drugs cleared through the FDA’s expedited review offer greater gains than drugs approved by conventional process
7 August 2017 - Chambers et al. investigated whether drugs approved by the FDA through expedited review have offered larger ...
Posted by Michael Wonder on 04 Aug 2017
FDA grants Genentech’s Alecensa priority review for initial treatment of people with ALK positive lung cancer
4 August 2017 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted ...
Posted by Michael Wonder on 03 Aug 2017
US FDA accepts regulatory submission for acalabrutinib and grants priority review
2 August 2017 - AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the ...
Posted by Michael Wonder on 01 Aug 2017
Indivior RBP-6000 NDA acceptance with priority review designation
31 July 2017 - FDA sets a PDUFA target action date of 30 November 2017. ...
Posted by Michael Wonder on 29 Jul 2017
U.S. FDA grants priority review for an epinephrine auto-injector in development by Kaléo specifically for infants and small children
27 July 2017 - AUVI-Q (epinephrine injection) 0.1 mg could be the first auto-injector approved with a needle length and dose ...