You are here: Industry Insights > FDA

News List

Introducing IMEDS, a Public-Private Resource for Evidence Generation FDA
January 18, 2017
FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry, to conduct large scale evaluations of safety issues in an environment that is sec
FDA Releases Final Guidance for "Nonproprietary Naming of Biological Products” americanpharmaceuticalreview
January 16, 2017
The Food and Drug Administration (FDA) has released the final guidance for industry "Nonproprietary Naming of Biological Products."
FDA Warns Cancer Patients Not to Use PNC-27 Products for Treatment americanpharmaceuticalreview
January 16, 2017
The Food and Drug Administration is warning consumers not to purchase or use PNC-27, a product promoted and sold through, as a treatment or cure for cancer. An FDA laboratory discovered the bacteria Variovorax paradoxus in a PNC-27 solution sample for inh
First US Service Members Treated with the Only FDA-Approved Cross-Linking Procedure in the U.S. americanpharmaceuticalreview
January 16, 2017
Avedro, Inc., an ophthalmic pharmaceutical and medical device company, has begun selling Photrexa Viscous® (riboflavin 5-‘phosphate in 20% dextran ophthalmic solution), Photrexa® (riboflavin 5’-phosphate ophthalmic solution) and the KXL® System to key mil
FDA accepts Mylan and Biocon’s biosimilar biologics license application europeanpharmaceuticalreview
January 13, 2017
The US Food and Drug Administration (FDA) has accepted Mylan and Biocon‘s biologics license application for MYL-1401O, a proposed biosimilar trastuzumab.
US FDA to re-audit Dr Reddy’s three plants financialexpress
January 13, 2017
The plants are located at Srikakulam, Miryalaguda and Duvvada
FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzum americanpharmaceuticalreview
January 13, 2017
Mylan and Biocon Ltd. have announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a propo
Aurobindo Pharma gets US FDA nod for its anti-epileptic drug and to acquire Portugal’s Generis for € firstwordpharma
January 09, 2017
Aurobindo Pharma has been granted final FDA approval to launch a generic version of HQ Specialty Pharma's epilepsy drug levetiracetam, livemint.com reported, Aurobindo Pharma to acquire Portugal’s Generis for €135 million.
FDA Approves Supplemental New Drug Applications to Include New Data in Product Labels for Synjardy®, americanpharmaceuticalreview
January 06, 2017
The U.S. Food and Drug Administration has approved supplemental New Drug Applications for three type 2 diabetes medicines within the empagliflozin family to include data from the landmark EMPA-REG OUTCOME® trial.
FDA grants priority review for Bayer’s liver cancer treatment europeanpharmaceuticalreview
January 05, 2017
The US Food and Drug Administration (FDA) has granted priority review status for the supplemental new drug application for Stivarga (regorafenib, Bayer), as a second line systemic treatment of patients with hepatocellular carcinoma (HCC) in the US.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 365 366 Next page