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FDA approves Roche’s lung cancer companion diagnostic europeanpharmaceuticalreview
June 07, 2017
The US Food and Drug Administration (FDA) have approved Roche’s VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible ...
BioPharma Services Completes 3 FDA Inspections contractpharma
June 06, 2017
BioPharma Services has completed 3 inspections this month by the U.S. FDA, with concurrent audits at both research centers in Toronto, Canada, and Columbia, MO.
Zydus Cadila gets US FDA nod for anti depressant expressbpd
June 06, 2017
Zydus Cadila has received the US health regulator’s nod to market Mirtazapine orally disintegrating tablets, an anti depressant, in the US market.
Protalix Wins FDA Approval as Multi-Product Facility contractpharma
June 05, 2017
Protalix BioTherapeutics received approval from the FDA for a Supplemental New Drug Application (sNDA) allowing the company to convert its manufacturing facility in Carmiel, Israel, from a single dedicated product facility to a multi-product facility.
FDA approves first generic Strattera for the treatment of ADHD europeanpharmaceuticalreview
June 01, 2017
The US Food and Drug Administration (FDA) has approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
FDA Advisory Committee recommends approval of Pfizer's proposed biosimilar to Epogen® / Procrit® acr worldpharmanews
May 27, 2017
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company's proposed epoetin alfa biosimilar across all indications.
FDA approves first cancer treatment for any solid tumor with a specific biomarker europeanpharmaceuticalreview
May 25, 2017
The US Food and Drug Administration (FDA) granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker).
FDA approves Kevzara for the treatment of moderately to severely active RA in adults cphi-online
May 25, 2017
Kevzara is now available to US patients.
FDA Slaps Clinical Hold on Concert Pharma (CNCE)'s Hair Loss Drug BioSpace.com
May 22, 2017
The U.S. Food and Drug Administration (FDA) placed a clinical hold on Concert Pharmaceuticals (CNCE)’ CTP-543 Phase IIa clinical trial for alopecia areata, a common autoimmune skin disease that causes hair loss.
FDA Warns Americans About Risk of Inaccurate Results from Certain Lead Tests drugs.com
May 18, 2017
The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States.

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