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FDA hands over full approval to AZ’ Tagrisso pharmatimes
April 07, 2017
US regulators have issued a full approval for AstraZeneca’s lung cancer drug Tagrisso on the back of a strong progression-free survival (PFS) benefit observed in a late-stage trial.
Indian FDA Approves the First Autologous Dendritic Cell-based Immuno-oncology Product, APCEDEN(R) en-cphi.cn
April 07, 2017
A first-of-its-kind Indian biotechnology company, APAC Biotech, was granted with a commercial license by Indian FDA (CDSCO - Central Drugs Standard Control Organization) to market product, APCEDEN®...
FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Cer drugs.com
April 07, 2017
The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions.
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).

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