LifeMax receives rare paediatric disease designation for LM-030 for the treatment of Netherton syndrome

18 July 2019 - LifeMax Laboratories today announced that the FDA granted rare paediatric disease designation to LM-030, an investigational therapy ...

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Durect announces that the FDA agreed to file the full response to the Posimir complete response letter as a complete Class 2 resubmission

17 July 2019 - User fee goal date is 27 December 2019. ...

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Trump to order drive for improved flu vaccine

16 July 2019 - President Donald Trump is readying an executive order that would direct HHS to overhaul the development ...

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U.S. FDA accepts Allergan's new drug application for bimatoprost sustained release in patients with open-angle glaucoma or ocular hypertension

17 July 2019 - Filing included data from the Phase 3 ARTEMIS studies, which demonstrated that the majority of patients remained ...

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FDA approves Merck’s Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with complicated urinary tract and complicated intra-abdominal bacterial infections where limited or no alternative treatment options are available

17 July 2019 - Merck  today announced that the U.S. FDA has approved Recarbrio (imipenem, cilastatin, and relebactam) for injection, 1.25 ...

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LogicBio Therapeutics receives rare paediatric disease designation for LB-001 for the treatment of methylmalonic acidaemia

16 July 2019 -  LogicBio Therapeutics today announced the U.S. FDA has granted rare paediatric disease designation to LB-001, a ...

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How pharma, under attack from all sides, keeps winning in Washington

16 July 2019 - It does not seem to matter how angrily President Trump tweets, how pointedly House Speaker Nancy ...

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Why isn’t insulin a complex generic? PA representative asks the FDA

16 July 2019 - Republican Mike Kelly (R-PA) sent a letter Tuesday to US FDA Acting Commissioner Ned Sharpless questioning ...

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Seattle Genetics and Astellas announce submission of biologics license application to FDA for enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer

16 July 2019 - Submission based on pivotal Phase 2 trial results recently presented at Annual Meeting of American Society of ...

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Dicerna receives breakthrough therapy designation for DCR-PHXC for treatment of primary hyperoxaluria type 1

15 July 2019 - FDA recognises primary hyperoxaluria Types 2 and 3 as meeting criteria for a serious or life-threatening disease ...

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Gilead and Novartis seek to expand what FDA considers as real-world data and real-world evidence

15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes ...

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FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab

16 July 2019 - FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises in patients ...

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FDA approves Bayer's Gadavist (gadobutrol) injection as the first and only contrast agent for use in cardiac magnetic resonance imaging in adult patients with known or suspected coronary artery disease

15 July 2019 - Coronary artery disease is an important public health issue-- a disease that affects 16.5 million Americans. ...

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The FDA disagrees with its own expert panels how often?

15 July 2019 - As the FDA grapples with rising pressure to approve new medicines more quickly, a new analysis ...

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Teva announces FDA approval of AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder

15 July 2019 - The first digital maintenance asthma inhaler therapy with integrated sensors joins Teva’s digital rescue inhaler therapy to ...

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