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RSS FeedPosted by Michael Wonder on 04 Jun 2021
FDA approves first treatment for patients with plasminogen deficiency, a rare genetic disorder
4 June 2021 - Today, the U.S. FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type ...
Posted by Michael Wonder on 04 Jun 2021
FDA authorises lower 1,200 mg intravenous and subcutaneous dose of Regen-COV (casirivimab and imevimab) antibody cocktail to treat patients with COVID-19
4 June 2021 - EUA supported by pivotal Phase 3 data showing 1,200 mg dose reduced risk of hospitalisation or death ...
Posted by Michael Wonder on 03 Jun 2021
HumanFirst joins the FDA, HHS and more than 20 organisations and leading health companies to launch the Digital Health Measurement Collaborative Community
3 June 2021 - Digital Health Measurement Experts will work together to develop best practices and streamline health measurement using digital ...
Posted by Michael Wonder on 03 Jun 2021
The big pharma firm that saw the future
3 June 2021 - Long ago Roche bet on personalised health care. Now its time has come. ...
Posted by Michael Wonder on 03 Jun 2021
U.S. FDA accepts PharmaEssentia’s BLA resubmission for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera
3 June 2021 - FDA assigns a new PDUFA action date of 13 November 2021. ...
Posted by Michael Wonder on 03 Jun 2021
Dermavant submits new drug application to FDA for tapinarof cream for the treatment of adults with plaque psoriasis
3 June 2021 - New drug application is supported by positive data from the Phase 3 PSOARING 1 and PSOARING 2 ...
Posted by Michael Wonder on 03 Jun 2021
Protagonist Therapeutics receives FDA breakthrough therapy designation for rusfertide in polycythemia vera
3 June 2021 - Designation further validates registrational path for rusfertide in polycythemia vera and facilitates potentially expedited development and review. ...
Posted by Michael Wonder on 03 Jun 2021
FDA grants priority review for new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa
3 June 2021 - PDUFA date of 30 November 2021 set for Oleogel-S10. ...
Posted by Michael Wonder on 02 Jun 2021
FDA approves pricey pill to treat vaginal yeast infections
2 June 2021 - Regulators OK’d a new anti-fungal treatment, but critics say it is unneeded and costs too much. ...
Posted by Michael Wonder on 02 Jun 2021
FDA authorises marketing of diagnostic aid for autism spectrum disorder
2 June 2021 - Today, the U.S. FDA authorised marketing of a device to help diagnose autism spectrum disorder. ...
Posted by Michael Wonder on 02 Jun 2021
Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application
2 June 2021 - Lupin today announced that the U.S. FDA has accepted the biologics license application for its proposed ...
Posted by Michael Wonder on 02 Jun 2021
Experts expect to see “second wave” of biosimilars approvals
2 June 2021 - Experts expect to see a second wave of biosimilar approvals, though continued Medicare Part D reimbursement challenges ...
Posted by Michael Wonder on 02 Jun 2021
Bausch Health and Clearside Biomedical announce U.S. FDA filing acceptance for Xipere (triamcinolone acetonide suprachoroidal injectable suspension)
2 June 2021 - PDUFA action date Is 30 October 2021. ...
Posted by Michael Wonder on 02 Jun 2021
Boehringer Ingelheim and Zealand Pharma receive FDA fast track designation for investigational treatment for NASH
2 June 2021 - FDA’s fast track designation for the GLP-1/glucagon dual agonist underscores the urgent need for new treatment options ...
Posted by Michael Wonder on 02 Jun 2021
Kedrion and Kamada announce FDA approval of Kedrab label update, confirming safety and effectiveness in children
2 June 2021 - New FDA approval based on safety and effectiveness of Kedrab in the paediatric population demonstrated in a ...