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

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…

AstraZeneca head and neck cancer trials resume as FDA lifts clinical hold

Industry news / 23 November 2016 / Niamh Louise Marriott, Digital Content Producer

The Phase III KESTREL trial has already re-opened for new patient enrolment at some clinical study sites and the EAGLE trial is expected to resume shortly….

Novartis’ acute myeloid leukaemia drug granted FDA priority review

Industry news / 18 November 2016 / Niamh Louise Marriott, Digital Content Producer

The FDA granted priority review to the PKC412 (midostaurin) new drug application as treatment for acute myeloid leukaemia…

FDA approves Bristol-Myers Squibb’s Opdivo as first Immuno-Oncology treatment

Industry news / 17 November 2016 / Niamh Louise Marriott, Digital Content Producer

Opdivo is the first and only Immuno-Oncology treatment proven in a Phase 3 trial to significantly extend overall survival for these patients…

Mylan and Biocon submit FDA application for Trastuzumab biosimilar

Industry news / 9 November 2016 / Niamh Louise Marriott, Digital Content Producer

Mylan and Biocon have submitted a biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, to the FDA through the 351(K) pathway…

FDA grants priority review for Novartis’ first-line treatment of HR+/HER2- advanced breast cancer

Industry news / 7 November 2016 / Niamh Louise Marriott, Digital Content Producer

The US Food and Drug Administration (FDA) accepted Novartis’ new drug application (NDA) for filing and granted priority review for LEE011 (ribociclib)…

UK regulatory support for Vtesse’s Niemann-Pick drug for children

Industry news / 4 November 2016 / Niamh Louise Marriott, Digital Content Producer

The MHRA has granted a Promising Innovative Medicine designation for VTS-270, Vtesse’s investigational drug for children with Niemann-Pick Type C1 disease…

Novartis wins “Discovery of the Decade” and “Best Biotechnology Product” awards

Industry news / 31 October 2016 / Niamh Louise Marriott, Digital Content Producer

Novartis has been awarded the 2016 Prix Galien USA Award “Discovery of the Decade” Award for Best Pharmaceutical Product for the drug Gleevec, as well as…

FDA approves Roche’s immunotherapy assay to support treatment decisions in lung cancer

Industry news / 31 October 2016 / Niamh Louise Marriott, Digital Content Producer

The US Food and Drug Administration (FDA) has approved Roche’s PD-L1 assay as a diagnostic to identify PD-L1 expression levels in patients considering treatment with Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer (NSCLC). The PD-L1 (SP142) assay is also indicated to identify patients with urothelial cancer (UC) who may benefit from treatment […]

Immune receives FDA guidance for acute myeloid leukaemia Phase III trial

Industry news / 28 October 2016 / Niamh Louise Marriott, Digital Content Producer

The proposed phase III study design reviewed by the FDA guidance focuses on overall survival as the primary endpoint, including Leukaemia Free Survival…

 

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