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FDA Approves Ingrezza drugs.com
April 12, 2017
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD).
FDA Grants Nanobiosym Diagnostics Emergency Use Authorization for Gene-RADAR® Zika Virus Test americanpharmaceuticalreview
April 12, 2017
Nanobiosym Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Gene-RADAR® Zika Virus Test.
Lupin receives FDA approval for generic Wellbutrin XL tabs financialexpress
April 11, 2017
The filing was done from Lupin’s Goa manufacturing facility and it will available in 150 mg and 300 mg capsules
RedHill Biopharma’s Yeliva obtains orphan drug designation from US FDA pharmaceutical-technology
April 10, 2017
RedHill Biopharma’s Yeliva (ABC294640) has secured orphan drug designation from the US Food and Drug Administration...
Supernus’ sNDAs receive final FDA approval for Trokendi XR for migraine prophylaxis pharmaceutical-technology
April 10, 2017
Supernus Pharmaceuticals has received the final approval from the US Food and Drug Administration (FDA) for its supplemental new ...
Merck receives CRL from the FDA for TECOS study with sitagliptin cphi-online
April 10, 2017
CRL relates to Merck's sNDA for Januvia, Janumet and Janumet XR.
FDA Commissioners Oppose Drug Importation lilly
April 10, 2017
Over the past few weeks, we’ve seen a variety of stakeholders raise concerns over drug importation legislation. Now, the leaders once responsible for the safety of our U.S. drug supply chain—FDA commissioners—are warning Congress of its life-threatening r
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.

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