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US Food and Drug Administration (FDA) - Articles and news items

FDA extends review period for Eli Lilly’s rheumatoid arthritis drug

Industry news / 16 January 2017 / Niamh Marriott, Digital Editor

Baricitinib is also being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus, and a phase 3 trial for patients…

FDA accepts Mylan and Biocon’s biosimilar biologics license application

Industry news / 12 January 2017 / Niamh Marriott, Digital Editor

This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers…

Ovarian assay

FDA approves Roche’s assay to assess ovarian reserve

Industry news / 10 January 2017 / Niamh Marriott, Digital Editor

The blood test produces standardised results for assessing ovarian reserve as compared with the use of vaginal ultrasound…

Aridis’ human monoclonal antibody pneumonia trial a safe success

Industry news / 9 January 2017 / Niamh Marriott, Digital Editor

AR-301 (Salvecin) is a fully human monoclonal IgG1 antibody that specifically targets S. aureus alpha-toxin and protects host cells from destruction…

FDA to review 3 new diabetes drugs that reduce cardiovascular death risk

Industry news / 5 January 2017 / Niamh Marriott, Digital Editor

In the trial, empagliflozin significantly reduced the relative risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack by 14%…

FDA grants priority review for Bayer’s liver cancer treatment

Industry news / 4 January 2017 / Niamh Louise Marriott, Digital Editor

The application is based on data from the placebo-controlled Phase III trial which investigated the drug as a second line treatment…

FDA clears Glenmark’s HER2+ cancer drug for Phase I trial

Industry news / 3 January 2017 / Niamh Louise Marriott, Digital Editor

Preclinical studies suggest GBR 1302 may have activity against a range of HER2-expressing tumour types, including breast, gastric and other cancers…

NICE and FDA team up for technology collaboration

Industry news / 20 December 2016 / Niamh Louise Marriott, Digital Editor

The National Institute of Health and Care Excellence (NICE) and the United States’ Food and Drug Administration (FDA) will team up, using technology to…

cardiovascular death

FDA approves drug that reduces risk of cardiovascular death in diabetics

Industry news / 12 December 2016 / Niamh Louise Marriott, Digital Editor

It significantly reduced the risk of (the combined primary endpoint) cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% versus placebo…

veltassa

FDA approves Veltassa following updated label warning regarding drug-drug interactions

Industry news / 5 December 2016 / Niamh Louise Marriott, Digital Editor

The updated US label for Veltassa recommends patients take Veltassa at least 3 hours before or 3 hours after other oral medications…

FDA clearance for Allergan’s refractory glaucoma treatment

Industry news / 5 December 2016 / Niamh Louise Marriott, Digital Editor

The XEN Glaucoma Treatment System reduces intraocular pressure in patients and is indicated for the management of refractory glaucomas…

FDA approval for Sanofi’s Soliqua to treat type 2 Diabetes

Industry news / 29 November 2016 / Niamh Louise Marriott, Digital Editor

Soliqua 100/33 is the combination of Lantus (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, studied in a Phase 3 program…

 

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