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FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss worldpharmanews
December 20, 2017
The U.S. Food and Drug Administration today approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness
US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cance worldpharmanews
December 19, 2017
AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has accepted the Supplemental New Drug Application (sNDA)
Admelog, the first short-acting “follow-on” insulin product for diabetes approved by FDA pharmaasia
December 18, 2017
The FDA has approved Admelog, a short-acting insulin product which can be used to help patients with diabetes control their blood sugar.
FDA Grants Orphan Drug Designation to Zytoprotec's Novel Dialysis Fluid b3cnewswire
December 15, 2017
Zytoprotec, a biopharmaceutical company developing innovative dialysis fluids, announced today that the United States FDA) has granted orphan drug designation to PD-protec®, the Company's peritoneal dialysis fluid for the treatment of patients with end-st
FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; i worldpharmanews
December 14, 2017
Today the U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance.
FDA approves vercise deep brain stimulation system biospectrumasia
December 13, 2017
Platform offers physicians advanced technology to treat symptoms of Parkinson's disease.
FDA launches public education campaign to encourage adult smokers trying to quit cigarettes worldpharmanews
December 12, 2017
Today, the U.S. Food and Drug Administration announced an adult smoking cessation education campaign aimed at encouraging cigarette smokers to quit through messages of support that underscore the health benefits of quitting
FDA approves pan-tumour genomic profiling assay biospectrumasia
December 11, 2017
FoundationOne CDx allows to assess genomic alterations in 324 genes known to drive cancer growth
FDA access programmes shaved up to a year off drug approval times, new study shows pharmafile
December 08, 2017
A research letter published this week has suggested that the FDA initiatives to accelerate drug approvals in the US could have shaved up to almost a year off the regulatory process.
US FDA approves Genentech’s Avastin for glioblastoma pharmaceutical-technology
December 08, 2017
The US Food and Drug Administration (FDA) has provided full approval for Genentech’s Avastin (bevacizumab) to treat adults with glioblastoma that progressed after previous therapy.

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