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RSS FeedPosted 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
Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine
1 June 2021 - EMA has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in ...
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 ...
Posted by Michael Wonder on 01 Jun 2021
BridgeBio Pharma receives FDA fast track designation for encaleret for the treatment of autosomal dominant hypocalcaemia type 1
1 June 2021 - BridgeBio Pharma today announced that the U.S. FDA granted fast track designation for encaleret for the treatment ...
Posted by Michael Wonder on 01 Jun 2021
Moderna announces initiation of rolling submission of biologics license application with US FDA for the Moderna COVID-19 vaccine
1 June 2021 - Moderna today announced that it has initiated the rolling submission process with the U.S. FDA for ...
Posted by Michael Wonder on 01 Jun 2021
Lannett announces FDA acceptance, as a priority original ANDA, of the generic Advair Diskus filing
1 June 2021 - Lannett today announced the U.S. FDA has accepted the abbreviated new drug application for fluticasone propionate and ...
Posted by Michael Wonder on 01 Jun 2021
Paratek Pharmaceuticals announces FDA approval of Nuzyra (omadacycline) oral only dosing regimen for the treatment of community-acquired bacterial pneumonia
1 June 2021 - Oral only dosing for the treatment of CABP expands the commercial opportunity for primary care promotion. ...
Posted by Michael Wonder on 01 Jun 2021
Mycovia Pharmaceuticals submits new drug application to the U.S. FDA for oteseconazole for the treatment of recurrent vulvovaginal candidiasis
1 June 2021 - Oteseconazole’s qualified infectious disease product and fast track designations allow for six month priority review by FDA ...