You are here: Industry Insights > FDA

News List

FDA puts Bristol-Myers Squibb Opdivo trials on hold pharmatimes
September 08, 2017
The FDA has placed a partial clinical hold on three trials related to Bristol-Myers Squibb's immunotherapy Opdivo after issues with trials for a rival drug.
Actelion Receives FDA Approval of TRACLEER americanpharmaceuticacreview
September 07, 2017
PAH is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected person.
FDA Grants Orphan Drug Status to ApoGraft for Acute and Chronic GvHD americanpharmaceuticacreview
September 06, 2017
Cellect Biotechnology announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Cellect's ApoGraft for the prevention of acute and chronic graft versus host disease (GvHD) in transplant patients.
FDA holds trials of Cellectis’ cell therapy after patient death pharmatimes
September 06, 2017
US regulators have placed on hold studies of French drugmaker Cellectis’ CAR-T therapy following a patient fatality.
FDA grants orphan drug status to Cellect’s ApoGraft europeanpharmaceuticalreview
September 06, 2017
The FDA has granted orphan drug designation for ApoGraft for the prevention of acute and chronic graft versus host disease…
Mylan and Biocon Herceptin biosimilar delayed by FDA for 3 months fiercepharma
September 05, 2017
Mylan and Biocon, which have had trouble getting to the regulatory finish line in Europe with their biosimilar of Roche’s blockbuster Herceptin because of manufacturing concerns, now face a three-month delay in the U.S.
FDA clears Adherium’s usage tracker for AstraZeneca inhaler fiercebiotech
September 05, 2017
Australian smart inhaler maker Adherium has scored an FDA nod for its SmartTouch device, for use with AstraZeneca’s Symbicort aerosol inhalers.
Pfizer’s Mylotarg receives FDA approval for acute myeloid leukaemia treatment pharmaceufical-technology
September 05, 2017
The US Food and Drug Administration (FDA) has granted approval to Pfizer’s antibody-drug conjugate (ADC) Mylotarg (gemtuzumab ozogamicin) for the treatment of patients with acute myeloid
New Steps To Strengthen FDA’s Inspection And Oversight Of Drug Manufacturing FDA
September 05, 2017
Manufacturing of drugs has become increasingly complex and global, requiring us to remodel our oversight of these tasks, to improve FDA’s efficiency and reach.
FDA approves Mylotarg for treatment of acute myeloid leukemia worldpharmanews
September 04, 2017
The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML).

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page