Enzyvant's investigational Farber disease enzyme replacement therapy, RVT-801, receives FDA fast track and rare paediatric disease designations

21 March 2019 - Enzyvant today announced that the U.S. FDA has granted are paediatric disease and fast track designations for ...

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Promoting biosimilars up to health plans, manufacturers, doctors, Gottlieb says

21 March 2019 - As he wraps up his final weeks as commissioner of the FDA, Scott Gottlieb, MD, talked about ...

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FDA approves new device for treating moderate to severe chronic heart failure in patients

21 March 2019 - The U.S. FDA today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure ...

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AbbVie is sued for using Humira patent deals to block competition in the U.S.

20 March 2019 - In a novel step, a New York union accused AbbVie and seven other drug makers of ...

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Jazz Pharmaceuticals announces U.S. FDA approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea

20 March 2019 - Sunosi is the first and only dual-acting dopamine and norepinephrine re-uptake inhibitor approved by the FDA to ...

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Biosimilar groups offer proposals to help US better mirror EU successes

19 March 2019 - With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups ...

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Biosimilar approval and adoption in the U.S. needs to be expedited

20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...

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Iterum Therapeutics receives QIDP for oral and IV sulopenem in four additional indications as well as fast track designation

19 March 2019 - New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the ...

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Novo Nordisk files oral semaglutide for US regulatory approval of glycaemic control, as well as for CV risk reduction for oral semaglutide and Ozempic

20 March 2019 - Novo Nordisk today announced the submission of two new drug applications to the US FDA for ...

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FDA reform: it’s time to act, but not as an independent agency

19 March 2019 - In a rare exercise in bipartisan leadership, former FDA commissioners of both political parties called, in ...

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FDA approves first treatment for post-partum depression

19 March 2019 - The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous use for the treatment ...

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Biosimilars Forum and Medicines for Europe call for changes to the US biosimilars market

19 March 2019 - The Biosimilars Forum and Medicines for Europe today released a joint white paper that discusses how Europe ...

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FDA approves Genentech’s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer

18 March 2019 - First new initial treatment option approved by the U.S. FDA for people with ES-SCLC in more than ...

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FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection

19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the ...

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Biohaven secures priority review voucher to expedite regulatory review of Rimegepant Zydis ODT new drug application

18 March 2019 - Rimegepant Zydis orally disintegrating tablet is Biohaven's lead oral CGRP receptor antagonist drug candidate from its Nojection ...

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