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RSS FeedPosted by Michael Wonder on 18 Jul 2019
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) ...
Posted by Michael Wonder on 18 Jul 2019
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 ...
Posted by Michael Wonder on 17 Jul 2019
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. ...
Posted by Michael Wonder on 17 Jul 2019
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 ...
Posted by Michael Wonder on 17 Jul 2019
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 ...
Posted by Michael Wonder on 17 Jul 2019
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 ...
Posted by Michael Wonder on 17 Jul 2019
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 ...
Posted by Michael Wonder on 17 Jul 2019
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 ...
Posted by Michael Wonder on 16 Jul 2019
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 ...
Posted by Michael Wonder on 16 Jul 2019
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 ...
Posted by Michael Wonder on 16 Jul 2019
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 ...
Posted by Michael Wonder on 16 Jul 2019
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 ...
Posted by Michael Wonder on 16 Jul 2019
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 ...
Posted by Michael Wonder on 16 Jul 2019
Caladrius Biosciences receives advanced therapy medicinal product classification for CLBS12, its CD34+ cell therapy for critical limb ischaemia
15 July 2019 - Caladrius Biosciences announced today that the EMA has granted Advanced Therapy Medicinal Product classification to the Company’s ...
Posted by Michael Wonder on 16 Jul 2019
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 ...