Patient registries may prove valuable in regulatory decisions, EMA study finds

18 July 2019 - Although patient registries can be heterogenous in their quality and design, a new study in Drug ...

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Was it really a smart move for the FDA to approve a ‘smart pill’ for treating schizophrenia?

18 July 2019 - In late 2017, the FDA approved the first so-called smart pill, ushering in a new era ...

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Horizon Therapeutics announces U.S. FDA acceptance of its new drug application to make Procysbi (cysteamine bitartrate) available as oral granules in packets

18 July 2019 - Horizon Therapeutics announced today that the U.S.FDA has accepted Horizon’s new drug application for Procysbi (cysteamine bitartrate) ...

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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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Knight Therapeutics announces Health Canada has approved Nerlynx for early-stage breast cancer

16 July 2019 - Knight Therapeutics announced today that Health Canada has approved Nerlynx (neratinib) for the extended adjuvant treatment of ...

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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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National regulator denied offer to give Canadian physicians training on abortion pill

16 July 2019 - The group representing Canada’s family doctors turned down an offer from a national abortion group to ...

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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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