You are here: Industry Insights > FDA

News List

FDA Reports Rare Cases of Liver Injury, Failure With Hep C Therapies drugs
August 30, 2019
The U.S. Food and Drug Administration has received reports of rare cases of worsening liver function or liver failure in patients with chronic hepatitis C virus (HCV) who had moderate-to-severe liver ...
FDA fast tracks AstraZeneca's FARXIGA biospectrumasia
August 29, 2019
FDA Grants Fast Track Designation for FARXIGA in Chronic Kidney Disease
Significant number of drugs on the market not yet fully approved europeanpharmaceuticalreview
August 29, 2019
A large number of drug manufacturers are failing to complete the FDA’s Accelerated Approval Program, meaning not all available drugs are fully approved, finds a study.
FDA grants Fast Track designation for Farxiga in chronic kidney disease worldpharmanews
August 29, 2019
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to delay the progression of renal failure...
FDA: Statement on the Agency’s Ongoing Efforts to Resolve Safety Issue with ARB Medications drugs
August 29, 2019
Protecting patients is the FDA’s highest priority, and Americans can be confident in the quality of the products the agency approves.
FDA approves new add-on drug to treat Parkinson's disease biospectrumasia
August 28, 2019
Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes
FDA fast tracks AstraZeneca's FARXIGA biospectrumasia
August 28, 2019
AstraZeneca has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patient
FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease drugs
August 28, 2019
The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes.
Lilly Receives FDA Approval for Ankylosing Spondylitis Treatment contractpharma
August 28, 2019
This is the third indication for Taltz, first approved for moderate to severe plaque psoriasis.
XTANDI® treatment granted priority review by FDA europeanpharmaceuticalreview
August 27, 2019
XTANDI® sNDA seeks to add an indication for men with prostate cancer that’s spread but is sensitive to hormone therapy.

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