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

Abeona Therapeutics receives FDA orphan designation for gene therapy

Industry news / 26 May 2017 / Niamh Marriott, Junior Editor

The FDA has granted Orphan Drug Designation for Abeona Therapeutics’s EB-101 gene therapy program for patients with dystrophic epidermolysis bullosa…

Motor neurone disease onset delayed by AI-discovered drug

Industry news / 25 May 2017 / Niamh Marriott, Junior Editor

The study assessed the efficacy of a drug candidate proposed by BenevolentAI’s artificial Intelligence technology for Motor Neuron Disease (MND)…

AstraZeneca announces collaborations to use CRISPR technology for genome editing across its drug discovery platform

FDA approves first cancer treatment for any solid tumor with a specific biomarker

Industry news / 24 May 2017 / Niamh Marriott, Junior Editor

The US Food and Drug Administration granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker)…

FDA approves Merck’s bladder cancer drug

Industry news / 24 May 2017 / Niamh Marriott, Junior Editor

The FDA has approved two new indications for Merck’s Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for bladder cancer…

Zika Virus assay for screening blood donations

Industry news / 23 May 2017 / Niamh Marriott, Junior Editor

Grifols now provides European countries accepting products with the CE marking with a test to detect the presence of the Zika virus in donated blood.

Alzheimer’s experts call for changes in FDA drug approval standards

Industry news / 12 May 2017 / Niamh Marriott, Junior Editor

Leading Alzheimer’s disease researchers published an analysis urging the FDA to clarify and modernise its approach for approval of Alzheimer’s drugs…

Roche receives FDA approval for bladder cancer biomarker assay

Industry news / 5 May 2017 / Niamh Marriott, Junior Editor

The FDA has approved Roche’s biomarker assay as a complementary diagnostic to provide PD-L1 status for patients with urothelial carcinoma…

formulation

AstraZeneca’s new formulation tablets receive positive CHMP opinion

Industry news / 5 May 2017 /

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the adoption of AstraZeneca’s Brilique (ticagrelor) 90mg orodispersible tablets (ODT) as a new method of treatment administration. This opinion is the first step towards the adoption of a new formulation of ticagrelor designed for […]

FDA approves Roche’s high-volume immunoassay

Industry news / 4 May 2017 / Niamh Marriott, Junior Editor

Roche’s new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyser series, the cobas e 801 module, has received 510(k) clearance from the US Food and Drug Administration (FDA). As core laboratories continue to evolve to meet the growing workload demands in an increasingly challenging environment, the cobas e 801 module offers greater […]

FDA approves new combination treatment for acute myeloid leukaemia

Industry news / 4 May 2017 / Niamh Marriott, Junior Editor

The drug is approved for use in combination with LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML…

bladder

AstraZeneca’s bladder cancer treatment receives FDA approval

Industry news / 3 May 2017 / Niamh Marriott, Junior Editor

The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) to treat metastatic urothelial carcinoma…

Kevzara

FDA accepts Sanofi and Regeneron’s biologics license resubmission

Industry news / 2 May 2017 / Niamh Marriott, Junior Editor

The FDA has accepted the resubmission of Sanofi and Regeneron Pharmaceuticals’ Biologics License Application for Kevzara (sarilumab)…

 

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