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Cantex Receives FDA Fast Track Designation for CX-01 americanpharmaceuticalreview
August 28, 2018
Cantex announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Cantex's lead product candidate, CX-01, for the treatment of patients over age 60 receiving induction therapy for newly diagnosed acute myeloid leukemia (A
Drugmakers large and small score FDA nods in busy week of approvals fiercepharma
August 27, 2018
A group of drugmakers large and small scored FDA nods in a busy week for the agency.
FDA Approves New Treatment for Rare Hereditary Disease americanpharmaceuticalreview
August 27, 2018
The U.S. Food and Drug Administration (FDA) approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the U.S.
FDA Adds Four Tropical Diseases to Priority Review Voucher Program americanpharmaceuticalreview
August 27, 2018
The U.S. Food and Drug Administration (FDA) announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to the list of tropical diseases.
Mallinckrodt, NPXe Announce FDA Fast Track Designation for Inhaled Xenon Gas Therapy Trial americanpharmaceuticalreview
August 27, 2018
Mallinckrodt and NPXe announced the United States Food and Drug Administration (FDA) recently granted Fast Track designation to NPXe's Phase 3 trial of xenon gas for inhalation in Post Cardiac Arrest Patients.
FDA Takes Action to Address Epipen Shortages americanpharmaceuticalreview
August 24, 2018
The U.S. Food and Drug Administration (FDA) took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3 milligram products marketed by Mylan by four months beyond the labeled
FDA Approves New Treatment for Seizures Associated with Dravet Syndrome americanpharmaceuticalreview
August 24, 2018
The US Food and Drug Administration (FDA) approved Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy.
FDA approves first drug for neurotrophic keratitis europeanpharmaceuticalreview
August 24, 2018
The FDA has approved the first treatment for neurotrophic keratitis, which completely healed the rare disease in 70 percent of cases.
FDA fights EpiPen shortage by extending expiration date for some devices fiercepharma
August 23, 2018
In the face of a shortage, the FDA has extended the expiration date of some lots of 0.3-mg EpiPen products from Mylan. (Mylan)
Agilent Companion Diagnostic Gains Expanded FDA Approval in Urothelial Carcinoma americanpharmaceuticalreview
August 23, 2018
Agilent announced that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma.

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