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RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 Jun 2021
Amryt announces FDA acceptance of new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa
2 June 2021 - Amryt today announces that the U.S. FDA has accepted for filing Amryt’s new drug application for Oleogel-S10 ...
Posted by Michael Wonder on 02 Jun 2021
Liquidia announces FDA acceptance of new drug application resubmission for LIQ861 (treprostinil) inhalation powder
2 June 2021 - Liquidia announced today that the U.S. FDA has accepted its new drug application resubmission for LIQ861 (treprostinil) ...
Posted by Michael Wonder on 02 Jun 2021
Scynexis announces FDA approval of Brexafemme (ibrexafungerp tablets) as the first and only oral non-azole treatment for vaginal yeast infections
2 June 2021 - Approval of Brexafamme (ibrexafungerp) represents the first approved drug in a novel antif-ungal class in more than ...
Posted by Michael Wonder on 01 Jun 2021
Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis
1 June 2021 - The safety profile of Cosentyx in paediatric patients with plaque psoriasis was demonstrated in two Phase ...
Posted by Michael Wonder on 01 Jun 2021
Novo Nordisk resubmits once weekly semaglutide 2 mg for the treatment of type 2 diabetes for US regulatory approval
29 May 2021 - Novo Nordisk today announced the resubmission of a label expansion application to the US FDA for the ...
Posted by Michael Wonder on 01 Jun 2021
CTI BioPharma announces acceptance of NDA granted with priority review of pacritinib for treatment of patients with myelofibrosis
1 June 2021 - PDUFA action date 30 November 2021. ...
Posted by Michael Wonder on 01 Jun 2021
Janssen announces U.S. FDA breakthrough therapy designation granted for teclistamab for the treatment of relapsed or refractory multiple myeloma
1 June 2021 - U.S. milestone follows EMA PRIME designation for this BCMA bi-specific antibody for the treatment of relapsed or ...