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drug approval

Independent consulting group, NDA, has announced its findings from its fifth annual comparison of drug approvals in Europe and the US in preparation for this year’s DIA Europe in Basel, Switzerland. more

Analysis

The European Medicines Agency (EMA) has approved Zebinix (eslicarbazepine acetate) for use as once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy. more

News

CPhI Worldwide Annual Industry Report member and president of EPCOT International, Girish Malhotra, has stated that if ANDA approval time is reduced from ten to three months the cost of drugs will be lowered. more

News

Recently published research from the Massachusetts Institute of Technology (MIT) and Mayo Clinic proposes a mathematical framework that may accelerate drug development. more

News

The FDA has approved the first drug for the treatment of adults with tardive dyskinesia, Ingrezza (valbenazine) capsules. more

News

An annual comparison of drug approvals in Europe and the US, performed by NDA Group, has found that there has been a drop in drug approvals in the US but not in the EU. more

News

During its March 2017 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including three orphans. more

News

An executive order signed by president Donald Trump to freeze all federal government hiring could negatively affect the US Food and Drug Administration’s (FDA) progress towards approving new drugs, medical devices and generic drugs. more

News

The US Food and Drug Administration (FDA) have granted accelerated approval to Genentech’s medication to treat people with bladder cancer more

News

Professor Sam Salek, School of Medical and Life Sciences, University of Hertfordshire, calls for a “universal framework” to speed up the disjointed decision-making process around the commissioning of new drugs more

Opinion

Novartis drug Odomzo gains approval for locally advanced basal cell carcinoma, providing non-invasive therapy for patients more

News

The new infographic draws on official data released from EMA and FDA more