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FDA grants Orphan Drug Designation to Epidermolysis Bullosa treatment europeanpharmaceuticalreview
December 10, 2019
The US Food and Drug Administration has awarded APR-TD011 Orphan Drug Designation, for the treatment of a rare disease.
Statement from the FDA on NDMA found in drugs outside the US europeanpharmaceuticalreview
December 10, 2019
The FDA has released a statement on the investigations into the presence of nitrosamines in some drugs; highlighting that there are currently no recalls of metformin within the US.
TechMah Medical & LimaCorporate Receive First 510k Approval for Smart SPACE Digital Technology En-CPhI.CN
December 10, 2019
LimaCorporate is pleased to announce the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Smart SPACE is an innovative digital platform developed ...
FDA slams repackager for unsupported drug expiration dates fiercepharma
December 10, 2019
The FDA has slapped around a U.S. drug repackager, saying in a warning letter that its storage processes and equipment cleaning are not up to expectations.
FDA launches app for health care professionals worldpharmanews
December 10, 2019
The U.S. Food and Drug Administration announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences ...
First investigational drug therapy for liver disease NASH awaiting FDA approval worldpharmanews
December 09, 2019
Patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease and a leading cause for liver transplantation in the U.S., currently lack an approved drug therapy ...
FDA Approves atezolizumab with nab-paclitaxel, Carboplatin for Metastatic NSCLC americanpharmaceuticalreview
December 09, 2019
The Food and Drug Administration (FDA) has approved atezolizumab (TECENTRIQ, Genentech Inc.) in combination with paclitaxel protein-bound and ...
FDA Grants ODD to Investigational Drug for Epidermolysis Bullosa americanpharmaceuticalreview
December 09, 2019
APR Applied Pharma Research (APR) has announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for ...
Johnson & Johnson Vision Announces New Monofocal Option for Cataract Patients americanpharmaceuticalreview
December 09, 2019
Johnson & Johnson Vision has announced the Food and Drug Administration (FDA) approval and U.S. launch of TECNIS Toric II 1-Piece Intraocular Lens (IOL).
Zotiraciclib granted Orphan Drug Designation by FDA and EMA europeanpharmaceuticalreview
December 09, 2019
The FDA and EMA have granted Orphan Drug Designation to zotiraciclib, currently the subject of two separate Phase Ib clinical trials in glioblastoma.

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