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J&J's Imbruvica scores fifth FDA lymphoma approval pharmafile
January 23, 2017
Johnson & Johnson’s Imbruvica (ibrutinib) has scored its fifth indication approval in the US for the treatment of Marginal Zone Lymphoma (MZL), this time in patients who require systemic therapy and have received at least one prior anti-CD20-based therapy
FDA Approves IMBRUVICA® as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Z americanpharmaceuticalreview
January 20, 2017
AbbVie has announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one pri
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.

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