FDA – Page 22 – media

Global generic drug approvals up in 2016

The USFDA said that it has achieved a year early the target set for 2017, to take action on 90% of the applications pending prior to the start of the Generic Drug User Fee Amendment Act (GDUFA) of 2012.
- Source: Ddu
- 568
- June 17, 2017
FDA generic drug Market Reports
FDA approval granted to Emmaus for sickle cell therapy

Emmaus Medical recently received FDA (The U.S. Food and Drug Administration) approval for sickle cell disease therapy Endari (L-gluitamine), ending two decades of drought for treatment of the disease and giving an alternative to the only other drug on the market, hydroxyurea.
- Source: fiercebiotech
- 537
- June 9, 2017
Company Insight FDA therapy
Second US approval for Merck, Pfizer’s Bavencio

Merck and Pfizer have announced a second accelerated approval in the US for Bavencio in less than two months, in this instance for certain patients with metastatic urothelial carcinoma.
- Source: pharmatimes
- 594
- May 10, 2017
cancer clinic Company Insight FDA gentic

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