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FDA grants Kitov waiver for new drug application filing fee europeanpharmaceuticalreview
April 07, 2017
The US Food and Drug Administration (FDA) has granted Kitov Pharmaceuticals a waiver related to the $2,038,100 new drug application filing fee for KIT-302.
FDA Accepts for Review the Application of IMBRUVICA® for Chronic Graft-Versus-Host-Disease (cGVHD) americanpharmaceuticalreview
April 06, 2017
Janssen Research & Development, LLC announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA®) ...
FDA Grants Kitov a Waiver for New Drug Application Filing Fee americanpharmaceuticalreview
April 06, 2017
Kitov Pharmaceuticals Holdings Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for...
US FDA approves Teva’s Austedo tablets to treat chorea associated with HD pharmaceutical-technology
April 06, 2017
Teva Pharmaceutical’s Austedo (deutetrabenazine) tablets have been approved by the US Food and Drug Administration (FDA) to treat chorea associated with Huntington’s disease (HD).
US FDA agrees to abridged clinical Phase III for Wockhardt’s WCK 5222 financialexpress
April 06, 2017
A combination of Zidebactam and Cefepime, WCK 5222 represents a new class of antibiotic treatment for AMR
Cipla receives US FDA approval for generic Epzicom tabs financialexpress
April 06, 2017
The tablets in combination with other antiretroviral agents are used for the treatment of HIV-1 infection
FDA approves Sanofi and Regeneron’s new eczema drug europeanpharmaceuticalreview
April 05, 2017
The US Food and Drug Administration (FDA) approved Sanofi and Regeneron‘s Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis).
AstraZeneca lung cancer drug receives FDA approval europeanpharmaceuticalreview
April 05, 2017
The US Food and Drug Administration (FDA) has granted full approval for AstraZeneca’s Tagrisso (osimertinib) tablets...
FDA approves first-ever atopic dermatitis biologic treatment pharmafile
April 01, 2017
Sanofi and Regeneron’s Dupixent (dupilumab) has become the first biologic medicine to be approved by the FDA for the treatment of moderate-to-severe atopic dermatitis (AD), the most common form of eczema, in adults when topical prescription therapies are
Trump's FDA pick vows to sever past pharma ties to avoid partisanship pharmafile
March 31, 2017
Donald Trump recently announced his top pick for Commissioner of the FDA as Dr Scott Gottlieb,Gottlieb has voiced plans to sever these connections to avoid any potential conflict of interest.

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