You are here: Industry Insights > FDA

News List

FDA in India – Championing a Culture of Quality FDA
March 30, 2017
One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States.
FDA Grants Priority Review for Eagle Pharmaceuticals’ Ryanodex NDA for the Treatment of Exertional H americanpharmaceuticalreview
March 28, 2017
Ryanodex NDA (dantrolene sodium) for the treatment of exertional heat stroke (EHS) has been accepted for filing and granted a priority review designation by the U.S. Food and Drug Administration (FDA).
Merck and Pfizer secure US FDA approval for Bavencio to treat skin cancer pharmaceutical-technology
March 28, 2017
Merck’s biopharmaceutical business EMD Serono and Pfizer have obtained the US Food and Drug Administration’s (FDA) approval for a 20mg/mL Bavencio (avelumab) injection to treat ...
FDA approves Parkinson's disease drug cphi-online
March 27, 2017
First NCE approved for PD patients with motor fluctuations in the US in more than a decade.
FDA Grants Breakthrough Therapy Designation for Rituxan®in Pemphigus Vulgaris americanpharmaceuticalreview
March 27, 2017
Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Rituxan® (rituximab) for pemphigus vulgaris...
FDA approves first treatment for rare form of skin cancer worldpharmanews
March 27, 2017
The U.S. Food and Drug Administration has granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior ch
US FDA grants Fast Track designation for Shire’s SHP655 pharmaceutical-technology
March 24, 2017
The US Food and Drug Administration (FDA) has granted Fast Track designation for Shire’s recombinant ADAMTS13 (SHP655 or previously known as BAX930) to treat acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP).
Clobetasol propionate is used for treating various skin disorders including eczema and psoriasis. biospectrumasia
March 24, 2017
The United States Food and Drug Administration (USFDA) has given its nod for Clobetasol Propionate Ointment, used for the treatment of various skin conditions.
Shire Receives FDA Fast Track Designation for Recombinant ADAMTS13 for Treatment of Hereditary Throm americanpharmaceuticalreview
March 23, 2017
Shire announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for recombinant ADAMTS13 (SHP655 - historically known as BAX930) for treatment of acute episodes...
FDA Approves Xadago® for Parkinson’s Disease Patients americanpharmaceuticalreview
March 23, 2017
Newron Pharmaceuticals S.p.A. announced that the Food and Drug Administration (FDA) has approved the use of Xadago® (safinamide) for the treatment of Parkinson’s disease as add-on therapy to levodopa/carbidopa.

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