Benefit-risk assessments at the US Food and Drug Administration: finding the balance

20 January 2017 - The US FDA’s independent evaluation of medical products for safety and effectiveness prior to granting approval ...

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Allergan announces FDA approval of Rhofade (oxymetazoline hydrochloride) 1% cream for the topical treatment of persistent facial erythema associated with rosacea in adults

19 January 2017 - Once daily treatment reduces persistent facial erythema associated with rosacea through 12 hours. ...

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FDA approves Trulance for chronic idiopathic constipation

19 January 2017 - The U.S. FDA today approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation in adult ...

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Statement from FDA Commissioner announcing FDA Oncology Center of Excellence launch

19 January 2017 - Today the U.S. FDA is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard ...

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What Trump's libertarian pals don't understand about the FDA -- or reality

18 January 2017 - Days before Donald Trump’s inauguration as President of the United States, there's already a reality-TV-sized dose ...

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U.S. FDA approves Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma - a rare type of non-Hodgkin's lymphoma

19 January 2017 - Imbruvica will be a chemotherapy-free option for patients with marginal zone lymphoma who failed prior therapies. ...

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Six month market exclusivity extensions to promote research offer substantial returns for many drug makers

18 January 2017 - To incentivise pharmaceutical manufacturers to invest in areas of unmet medical need, policy makers frequently propose extending ...

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Boehringer Ingelheim biosimilar candidate to Humira accepted for EMA and FDA regulatory review

18 January 2017 - BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim. ...

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FDA grants fast track designation for aTyr's Resolaris to treat limb girdle muscular dystrophy 2B and removes partial clinical hold for Resolaris

18 January 2017 - First reported fast track designation for LGMD2B treatment. ...

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FDA issues long-awaited biosimilar interchangeability guidance

17 January 2017 - The US FDA has finally released for public consultation its long-awaited draft guidance detailing the agency's ...

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Teva receives FDA approval for Vantrela ER (hydrocodone bitartrate) extended release tablets formulated with proprietary abuse deterrence technology

18 January 2017 - Vantrela ER label describes the product’s abuse-deterrent properties against abuse in the three most common routes—oral, ...

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FDA approves a generic of Xyrem with a REMS Program

17 January 2017 - The U.S. FDA has approved the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat ...

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FDA Advisory Committees: independent, informed, essential and evolving

18 January 2017 - One of the most common concerns raised when I meet with medical leaders is the need ...

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Statement from FDA Commissioner announcing new draft guidances on medical product communications

18 January 2017 - We recognise that there is a high level of interest regarding FDA’s views on communications about ...

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Will cardiovascular outcomes data on newer diabetes drugs bury the older agents?

17 January 2017 - Patients with type 2 diabetes are treated with many drugs other than insulin. In 2014, Medicare paid ...

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