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Bora Secures FDA Approval for CDMO Services contractpharma
September 04, 2019
Bora, a contract development and manufacturing organization (CDMO) that specializes in modified release (MR) and solvent production, has reported a successful FDA general inspection for its facility in Zhunan...
anti-BCMA autologous CAR-T cells (CT053) receives US FDA orphan drug designation biospectrumasia
September 03, 2019
Under the Orphan Drug Act, the CT053 anti-BCMA product would be eligible for certain benefits including seven years of market exclusivity in the United States following marketing approval by the FDA.
FDA approves Kyowa Kirin’s Nourianz drug for Parkinson’s disease pharmaceutical-technology
September 03, 2019
The US Food and Drug Administration (FDA) has approved Japanese company Kyowa Kirin’s drug Nourianz (istradefylline) as an add-on to the existing drug levodopa/carbidopa to treat adults...
FDA Warns of Liver Injury with Mavyret, Zepatier, Vosevi americanpharmaceuticalreview
September 03, 2019
The Food and Drug Administration (FDA) has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases...
FDA Announces Director, CVM Office of Research americanpharmaceuticalreview
September 03, 2019
The U.S. Food and Drug Administration (FDA) announced Regina Tan, DVM, MS, has joined the agency’s Center for Veterinary Medicine as the director of the center’s Office of Research.
Glenmark Receives ANDA Approval for Pimecrolimus Cream, 1% americanpharmaceuticalreview
September 03, 2019
Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (FDA) for Pimecrolimus Cream, 1%, a generic version of Elidel® Cream, 1%, of Bausch Health US.
FDA red-flags liver risks for AbbVie, Merck, Gilead hep C drugs fiercepharma
September 02, 2019
Next-gen hepatitis C meds typically cure the disease with minimal side effects. But the FDA says it's tracking rare cases of liver damage, liver failure and death in patients using some top-selling drugs—mostly patients who shouldn't have been using the d
FDA announces expansion of generic impurity investigation europeanpharmaceuticalreview
September 02, 2019
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
Small molecules dominate FDA drug approvals this month europeanpharmaceuticalreview
September 02, 2019
This August saw nine new green lights from the FDA, all small molecules, which makes up a third of the approvals this year.
FDA: Risk From Tainted Blood Pressure Drugs Very Low drugs
August 30, 2019
The health risk from contamination of widely used generic blood pressure medications, angiotensin II receptor blockers, is very low, according to the U.S. Food and Drug Administration.

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