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FDA Grants Orphan Drug Designation for Ganaxolone in CDKL5 Disorder firstwordpharma
June 30, 2017
FDA Grants Orphan Drug Designation for Ganaxolone in CDKL5 Disorder
FDA Approves Vectibix (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer firstwordpharma
June 30, 2017
FDA Approves Vectibix (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer
FDA creates team to tackle backlog of orphan drug designation requests firstwordpharma
June 30, 2017
FDA creates team to tackle backlog of orphan drug designation requests
FDA Grants Priority Review of 10 mg XARELTO to Reduce VTE Risk americanpharmaceuticalreview
June 29, 2017
Janssen Research & Development announced the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) to include a 10 mg once-daily dose for reducing the risk of VTE after at
FDA grants fast track designation to Synlogic’s SYNB1020 synthetic biotic treatment pharmaceutical-technology
June 29, 2017
Synlogic has received fast track designation for its lead product candidate SYNB1020 from the US Food and Drug Administration (FDA).
US FDA approves Natco’s ANDA for generic version of Vidaza expressbpd
June 29, 2017
Natco and Breckenridge Pharmaceutical plan to launch the product in the US market
FDA tackles drug competition to improve patient access worldpharmanews
June 29, 2017
Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.
Pfizer’s biosimilar gets another FDA rejection biospectrumasia
June 28, 2017
FDA complete response letter (CRL) cited concerns about the same Pfizer fill-finish plant whose problems led the FDA to deny approval of a highly anticipated copy of Teva’s Copaxone that was to be finished there.
FDA approves 510(k) clearance to Ortho’s VITROS Insulin reagent and Calibrators biospectrumasia
June 28, 2017
An important biomarker in diabetes and pre-diabetes testing, the assay is expected to be commercially available for use on all of Ortho's VITROS Immunodiagnostic and Integrated Systems in the U.S. during the third quarter of this year.
FDA approves cryopreserved formulation of ReNeuron’s candidate europeanpharmaceuticalreview
June 28, 2017
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate…

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